“Being a partner has given vendors permission to underperform.”
It is most fashionable these days to describe all business relationships as “partnerships.” It doesn’t matter if we are licensing a compound, handing off functional operations to a CRO or buying a piece of software, we are always doing it with “partners.” I suppose the paper distributor who supplies our paper towels is our “cleanliness assurance partner.” While we can dismiss this language as the marketing cover-up that originated its usage, we cannot so easily dismiss how misperceptions resulting from this language have become an obstacle to the theoretical concept behind the word.
Everyone wants to be our partner these days, even when they are simply selling us a product or service. I have to wonder what is wrong with being “just” a provider or a vendor these days? The glib answer is that somehow partners provide us “more”, while in my observation they actually provide us less. Being a partner has given vendors permission to underperform, especially to the unreasonably high expectations they have set for themselves with this partner language. By being our partner, more can be blamed on us and less on them. Being “all in this together” somehow has shifted more oversight, more responsibility, and more strategy burdens onto us and away from the vendor. It’s a marvelous marketing ploy. Woe to all of us if the IRS announces tomorrow that they have now become our partner! Or to use the Latin, caveat socius!
Symptoms
The partnering game plays out in clinical research information technology in a myriad of ways. First off, all the software vendors are of course now our partners, not our vendors. This has become a business necessity because a) (see above) everyone is a partner, and b) they are under-performing as simply “vendors.” So claiming the partner mantle is an attempt to avoid attention on their:
— inadequate support performance
— stagnant product performance
— need for a steady revenue stream
— slow product migration /enhancements
— serially monogamous innovation.
The state of clinical IT products and services in 2009 is a stagnant pool, and the algae are starting to grow on the edges. Most vendors of EDC, CTMS, ePRO, AES and related tools are evenly modest in their support capabilities: every sponsor has learned that the quality of service they receive from a vendor depends entirely on who the vendor project manager is that month, that help desks consist of thinly prepared outsourced staff, and that vendor training is increasingly automated and automatic.
Meanwhile product lifecycles have matured. It is not an exaggeration to say that the functions and features of the leading tools in all clinical IT spaces today are barely distinguishable from those 7-8 years ago.
Money of course is a key contributor. Vendors need to partner with us because they need a steady stream of revenue. One cannot sustain a software business in our industry by selling large boluses of perpetual licenses because you’ll run out of biopharma customers too quickly. So the game is to get sponsors to subscribe to a variable-dependent service (per trial, per program, per year, per something) so that the income will never end. Much better (from their marketing perspective) for us to think of this company you will never stop paying as being a partner, rather than a vendor.
Partnering is a great method for distracting the customer from what is missing in the product strategy (which is harder to hide if they admitted that, after all, they are a product supplier). As the core products stagnate, customers are making longer lists of desired (or required) functional enhancements. They want to see a practical vision for technology migration, and especially now, technology integration. But enhancements and integrations are not in the vendors’ fundamental interest. There is simply not enough money to be made in helping out with these things – the revenue to be made will never cover the engineering costs.
This is compounded by the vendors’ “serial monogamy” approach to functionality: vendors develop, or enhance, or acquire a functional solution one at a time, without particular regard to interoperability or revisiting their customers’ needs every once in a while. Vendors are still approaching our market one silo at a time, even when the shape of sponsor clinical development is rapidly morphing into…well, something unknown, but definitely something not well-served by automating the 1970’s. So not only are sponsors not satisfied, but the vendors themselves are starting to drift, as the end of innovation sucks the energy out of the market.
Worsening
Gee, that sounds like a dark picture on today’s vendors. Perhaps, but it is realistic. And sponsors are feeling the situation getting slowly worse. Why would this be?
— Takeovers, spun as “consolidation”, which is supposed to be good for us (mimicking sponsors perhaps?), leading to, at a minimum, enormous distraction, and usually to overlapping sets of software and therefore delayed product growth strategies or enhancements, as well as confused support services.
— Tough financial times – true for everyone, but software vendors who never did understand the actual clinical research application of their products are now less likely than ever to hire or retain the “subject matter” professionals who otherwise are not programming or selling.
— Sponsor disarray – the tough times and takeovers affecting sponsors means fewer sponsor resources for vendor management, informed contract management, internal process analyses and continuous improvement, and so on. This results in poor policing of the vendors and poor communication management between even the best vendors and deepest sponsors.
First, Change the Language
How do we get out of this mess? The first step lies in the language: we are not partners with our software vendors, we are buying something from them. We have expectations for what we are buying which they need to meet. This needs to be managed not as if we were lawyers in the same law firm, but rather as customer and provider. We are most definitely sitting across the table from each other, not side by side. As promising as the partnership mystique has seemed, the results have simply not been there, and a return to buyer and seller is not demeaning or a failure, but rather an ancient, proven method of achieving buyer satisfaction.
And More
The good news is that there are practical steps for sponsors, easily within our grasp, to reclaim control over a software market we depend on, but which has gone flat. These steps take a little money, but mostly they take willpower:
— Dedicate internal resources fulltime to projects that manage, specify, or implement new information technologies into the clinical research process
— Insist on transparency from the vendors – we have the right as customers to know their true plans, their staffing (and qualifications thereof), how and why they price their services, what is the likelihood of enhancements, and so on
— Professionalize vendor management internally, and understand this is a fulltime job without which our software or service providers will fail us
— Take back the initiative on vendor contracts from the vendors.
Despite the rise in power and scope of sponsor contracting groups, they generally have not helped this situation I have described because they do not sufficiently understand either the software business or clinical research operations. For instance, if software enhancements are not in vendors’ fundamental interest, then sponsors need to structure a relationship that makes it so, including considering taking back the strategic leadership of this vendor space.
If we can’t get what we want from vendors, it means we are not applying our vast resources of talent and money to get it. This is not rocket science. It’s not even drug discovery. Rather, maybe clinical development really is too small a market to leave to the vendors, and too important to us to leave it to them.
What will make the vendors cooperate with such radicalism? Vendors must remember that it isn’t scary anymore for a sponsor to change EDC vendors, even enterprise commitments, on the fly. It is happening regularly now. Such changes have always frequently happened in the ePRO space. And it would not be that much out of the question to do so with CTMS (because none are satisfactory) or AES (because they are all the same). So caveat venditor as well.
Let’s take the energy we’re spending hugging our partners and turn it towards communicating with, and managing, our vendors effectively to deliver what clinical development needs in the coming years.
“In Hollywood now when people die they don’t say, “Did he leave a will?” but “Did he leave a diary?”” — Liza Minelli
The importance of collecting patient reported outcome data in biopharma research is increasing rapidly. The recent geometric explosion of technological innovation has brought about the introduction and use of electronic diaries to fulfill this purpose. We have reached a point when it is no longer cost-prohibitive or technologically infeasible to collect almost any type of data via electronic means, but this capability has outpaced our operational methodologies and capabilities for the successful large-scale implementations now required. This is one important reason why electronic diary adoption is so much slower than EDC at the moment.
The broad term used for the collection of patient-reported (as distinct from investigator-recorded) data is ePRO (Electronic Patient Reported Outcomes), which encompasses a wide range of so-called “instruments” (series of questions, not hardware) and instruments (hardware) administered in a variety of ways (completed in real-time, or otherwise; completed by patient directly, or otherwise; etc.). In this column, however, I want to focus on the most challenging (but often most important) format of ePRO – the electronic diary.
While use of the common telephone is a common resource for ePRO when data collection requirements are simpler, a full-fledged patient diary requires technology in the handheld and tablet format, where it seems that every few months a new gadget emerges that can do something which simplifies one’s life and makes it that much more complicated at the same time. The data collection options are no longer limited to answering a question. We are now able to visualize the question textually and diagrammatically before providing an answer. We can easily record the exact time and date the answer was provided, limit when and how often the answer can be given, send reminders to prompt for that answer and if we want to get really personal, record the exact location of where that answer was given and have a photograph taken of the person giving the answer. These types of mainstream technological enhancements may pave the way for potential ad hoc analyses of how location could affect an answer (temperature, climate, urban, rural), or provide additional biometric markers in relation to the emotion of the person at the time they were giving an answer. I will not attempt to address the scientific validity of any of these measures, rather the point is to illustrate that enhanced capability and operational complication are directly related, and the latter is often overlooked in favor of the former.
It’s So Easy
What could be so difficult about answering a question on a device which asks you to push a button or select an option with a stylus? This is a common view, and a common misperception of technology providers and sponsors using ePRO. We are so used to dealing directly with sites and personnel who are experienced in the conduct of clinical research that we forget our nice new gadget is now in the hands of the general public, who are by definition not in the research data management mainstream. Not only have we failed to adequately address this fact, but rather have exacerbated the problem by not providing adequate training on how to use these devices for our trials. The training, as with other technologies (EDC), is often considered to be of ancillary importance. We hope that in one, three-hour, session at an investigator meeting, not only will sites become experts on the ePRO device and survey use, but they will also be able to convey this knowledge in a simplified manner to the inexperienced end user. As expedient as this is to sponsor and vendor, it is unfortunately not sufficient to the public user upon whom the data (and study results) now depend.
To further complicate matters, the tendency has been to take full advantage of the capability of the technology to collect ultimately extraneous data. Once again we forget the end user and direct our attention to the almost limitless potential to collect multiple points of data for theoretical ad hoc analyses, often losing site of the primary datapoints we are interested in. It is a classic case of allowing the details and options to confound and overwhelm the intended purpose. I am reminded of the time when a relative of mine from South Africa first walked into a supermarket in the USA in search of a loaf of bread. She was so used to having only two choices — “wheat or white” — that she was overwhelmed by the number of choices available to her and walked out without buying. The second time she went, she returned with fifteen loaves of all different breads — one was eaten and the rest spoiled. And so too it is easy to lose focus when presented with multiple possibilities and end up with lots of extraneous, unutilized data that took a large amount of effort to collect.
Where in the World is Carmen’s Diary?
Globalization is another area which has been recognized as a significant challenge in the implementation of ePRO. Our diary writers now live all over the world, speak many different languages and is recording data every hour of every day of the year. There are two primary challenges in getting patients to use the diary correctly: 1) actually getting the device to them in the first place and, 2) providing them support once they begin using the device.
The provisioning challenge stems directly from the fact that despite all of the innovation we are still using a local piece of hardware that has to be shipped, inventoried and repaired or replaced if damaged. Using ePRO globally will require that sufficient lead times are considered to address issues such as, shipping, customs, and local couriers, not to mention algorithmic calculations to allow for adequate inventory management related to expected screen failures and completed patients. This inventory balance is especially difficult considering the cost replacement (device cost, image loading costs, QA) and the importance placed on missing pieces of data that are irretrievable and thus un-analyzable. It is evident that one cannot record data in the device if they do not have access to it and the technology loses its primary benefit of real time recording, if the contingency is to back enter data once a new device becomes available.
One may ask, “gee, sounds like EDC in the ‘90’s; the Internet took care of that, didn’t it?”. For obvious reasons, the Internet does not quite yet supersede dedicated hardware for ePRO. If protocols call for true, frequent, real-time recording of data, then reliable Internet access – even through enabled smartphones – is not dependable in most areas of the world (try running errands in your hometown all day and think about hourly recording of your symptoms through your smartphone being dependent on a WiFi connection).
I Just Called to Say…I Don’t Understand You.
Another crucial aspect of globalizing ePRO is providing ongoing support to subjects for any questions or technical difficulties that may arise. The difficulty here cannot be exaggerated. It is a very different proposition to be supporting the average trial subject in the use of technology than it is to support clinical research professionals (monitors, etc., as we are used to). There are few if any large helpdesk providers that are familiar enough with this technology to be effective, and supporting an endless number of languages within a manageable cost structure is next to impossible. Vendors have tried to solve this problem by locating their helpdesks in exotic locations claiming multi-language support, when in fact the focus is more on cost-savings due to lower hourly rates. The result is a frustrated subject who spends the majority of the phone call trying to find a person that s/he can understand. This frustration typically leads to lower compliance and a real hesitancy on the part of the sponsor and to use the technology again.
Lead Me to the Landfill
Technological innovation, for all its positives, has left us with an important underlying problem: technology outpaces clinical trial timelines. This puts sponsors in the position of having to continually re-purchase new hardware as the device they used for their previous trial is no longer supported or obsolete. Many argue that this is the cost of doing business and that the capital expense is “the pill you swallow” for the benefit of real time and accurate data. However, in the current economic environment, vendors should be thinking about options that are not hardware-dependent and that can be leveraged across trials. Not only would this go a long way in helping solve part of the provisioning problem, but would also allow some recognizable cost-savings that can be realized across large programs, which currently is a barrier to sponsor acceptance. There is no question that for the most part, for the new generation of clinical research subjects, the technology learning curve will decline. Web access, and its inherent detachment from any one piece of hardware, will undoubtedly help the current hardware dependencies but the solution is not immediately at hand, and sponsors need to be using ePRO now. So much work remains to be done by vendors and their customers alike.
There is little question of the value of collecting patient reported outcomes electronically, and it is clear that the industry in general is moving towards this methodology in the same way they have been doing with EDC for the past decade. Our excitement and acceptance of the innovations of today and tomorrow should not distract us from the importance of operational changes and procedures that play a significant role in realizing the benefit of this innovation. If we can achieve operational excellence in ePRO, we have a chance to overcome temporary barriers to ePRO acceptance.
There’s no time like tough times to get people to accept improvements to the status quo.
In these difficult times, we should step away from software details for a moment and think about what the technology industry can teach biopharma about dealing with a recession. There is a lot to learn, a lot to teach. Pharmaceutical companies have been mostly immune from the hard times that “high tech” has gone through severely at least twice – the late 80s/early 90s minicomputer/telecomm slide, and the dotcom bust at the turn of the century. In both instances, technology companies were leading the way in paying for major strategic mistakes, poor crisis management, and large doses of hubris. Pharma, clinical research technology companies, and consumers of clinical research technology all have lessons to learn from these experiences.
Lessons for Pharma
Large organizations faced with relatively sudden financial setbacks will tend to follow one of two suboptimal paths:
• Make broad, universal, indiscriminate cuts with little consultation with middle management; or
• “Hope for the best”, turn the unfamiliarity with the circumstances into a virtue, and try to hold on with minimal cuts.
The first option is usually quite damaging – the cuts are made purely on financial metrics, and targets are handed down through the management chain without a re-evaluation of corporate purpose, direction, competencies and sources of cost. Being relatively indiscriminate, cost-cutting in this way is demoralizing to staff, producing a degree of cynicism, and leaves middle management struggling with arbitrary new staffing levels.
The second option is equally or more damaging, and is likely to be more common in pharma. One can call this “death by a million little jabs”. One too-small layoff leads to another too-small layoff, and another, seemingly endlessly. The best staff will flee the company because the lose faith in management’s hold on the situation and cannot abide the dark cloud which now hangs over the office. Rather than one cataclysmic disruption (which staff can put behind them if they know it’s over), the piecemeal method is particular disruptive to the project team approach which almost all clinical development staff are working in. The uncertainty of “who’s next” can take up half your day. The project may continue but be underfunded. Reserve funds to handle clinical trials’ inevitable surprises may have dried up. And many staff may be more focused on looking to what other company they should jump to rather than the project at hand.
How does a company handle hard times more effectively? The answer of course would lie in many books, not a paragraph, and will depend on your company’s inherent strengths, weaknesses and personality. But judging from high tech’s failings over the last quarter-century, four things come quickly to mind:
One way to avoid the dilemma described above is to know who or what you want to keep, and how to do so, ahead of time. In other words, you should have been planning for this, and if you haven’t, it’s never too late to try to catch up. You always have a chance to improve your downsizing performance so that your recovery performance will outshine the competition and protect your employees best. So make a plan, and continually update it. It should be not just about individuals, but about core competencies and fact-based evaluations of productive and non-productive corporate activities.
Use unusual times to do business unusually. It will sound callous to those losing their jobs, but tough times create an opportunity –very rare in large, traditionally successful companies like pharma – where steps can be taken that would never be risked in normal times. If ever there wasn’t a time to say “we always do it that way,” it would be now. And this extends from the boardroom to the study team conference room.
Overcome traditional resistance to change and implement those process efficiency improvements. Every company has lots of good ideas for improving operational efficiency already sitting on their shelves. Long delayed because of entrenched political resistance or the feeling that we don’t have any time, there’s no time like tough times to get people to accept improvements to the status quo even if they are not ready for dramatic upheaval.
Sustain executive visibility, throughout whatever activities you pursue. A common mistake in tough times is for executives to disappear behind closed doors and worry themselves to distraction while creating widespread mistrust and rumor-mongering in the hallways. Top leadership should be more visible, not less. Answer the questions you can, think about the staff feedback you are getting, and let staff know you still care for them and what they are working on.
Lessons for Clinical Research IT Companies
Clinical research information technology companies are especially vulnerable in this recession, because almost none of their leadership has lived through times like these in this market. This compounds the fundamental fact that most clinical IT companies are extremely small, economically fragile, too dependent on a small number of customers, and equally too dependent on a handful of key staff who might be driven to leave in times of such uncertainty. The lessons for these companies from high tech’s past are those most likely to seem counter-intuitive:
Maintain or expand your marketing presence: reassure your customers that you are still here and are strong enough to be a worthy partner.
Maintain or expand customer service: at this point, your services are more important than your technology features. Improving customer satisfaction builds lifesaving loyalty in tough times.
Innovate in services and in cheap feature delighters: a little will go a long way in these times. Demonstrate that you are still investing in your product, and that you know your customers’ needs well, by bringing new value to market, however modest.
Lessons for Clinical IT Consumers
Clinical IT consumers have to combine a good understanding of both sets of lessons above. You have the responsibility to continue excellent operational execution regardless of the financial atmosphere. So:
Look for management maturity from your supplier – one can hope that might mean they will handle these times more steadily.
Look for simplicity and robustness in your solution choices – they will make your tools easier to maintain in lean times.
Implement rigorous but supportive vendor management – despite the burden, you will need to spend more time managing your vendors, more closely, and yet this can be supportive to the vendor and make the difference between confidence and bankruptcy.
It’s no fun for anyone right now. Knowledge is the best defense against an uncertain future, besides luck, which I wish to all of us.
Bigger isn’t better, smaller isn’t better. Only better is better.
The past year has seen considerable turmoil in the vendor spaces generally considered “clinical IT”: EDC, CTMS, ePRO. While there continues to be new vendors (which in the EDC space is somehow miraculous), the notable occurrences have been changes in ownership and/or near bankruptcies. For those of you not keeping score at home:
• Oracle, now has not one but two CTMS’, having inherited Siebel’s eClinical as a side-effect of the Siebel parent acquisition (their other CTMS being the acquired SiteWorks).
• PF acquired a collection of what marketers call “line extensions”, including LabPas for Phase I studies (the company was called Green Mountain Logic), and Clarix for IWRS (interactive web response), plus announcing various partnerships for imaging and such.
• Parexel (under the Perceptive Informatics umbrella) acquired ClinPhone, which gave them a trifecta of overlapping new stuff: like Oracle, they now have two CTMS’s (they already had IMPACT, and ClinPhone brings the very recently acquired TrialWorks); a second attempt at EDC (the old Datalabs, also very recently acquired by ClinPhone; SiteBase being Parexel’s first EDC go-around in the 1990’s); and of course more IVRS/IWRS capabilities, which was what Perceptive already offered, in addition to imaging.
• Meanwhile, Datatrak and etrials have their stock values teetering on the edge (again), while lots of new EDC players fearlessly turned a blind eye to history and entered the market fresh.
The question for clinical trial professionals, all of us increasingly dependent on the software made by these vendors, is, does any of this matter? In theory, of course, it matters very much. And even in practice I think it can matter; the question is whether it matters positively (as the “new” vendor incarnations will assure you), or negatively (as skeptics will automatically and unfairly assume). Let’s look at why it may or may not be good for you.
The Good
Merging eClinical vendors brings the potential for several improvements in clinical research IT:
• The more individual application niches (EDC, CTMS, IVRS, etc.) that one company owns software for holds out the hope that these tools can finally be meaningfully, functionally, integrated – a nirvana devoutly sought by all.
• Moving beyond getting current software to talk to each other, one company covering multiple niches could actually develop tools offering completely new functionality exploiting all the features we need from a singular design point-of-view.
• Bringing software under one roof could bring improved account servicing and coordinated project management.
• Fewer vendors is probably better, especially in the EDC space, considering the resources vendors commit to hacking their way through the forest of today’s multitudinous vendors.
• Theoretically, the acquirer is financially stronger, has more feet on the ground, and is administratively more competent.
• More revenue to the acquirer should further strengthen the acquirer.
• Sponsors look favorably at larger vendors as being more stable, long-term partners (although the average large trial budget is much larger than the annual income of almost any eClinical vendor).
Overall, the advantages of these mergers are mostly speculative, and so far we’ve seen more good intentions than tangible benefits from any of the moves in the eClinical marketspace.
The Bad
Few companies in any industry do mergers and acquisitions well. There is a myriad of personnel issues, financial structure compatibilities, product line clashes, strategic differences, executive egos, geographic considerations, and pricing turmoil which accompanies every such move, and clinical IT vendors are not immune. Most of these problems have plagued every clinical IT company maneuver in the past decade. A handful of companies have emerged stronger, albeit usually despite their suboptimal handling of the problems, while a larger number have been severely handicapped. So as new moves are announced, sponsors should view them first with trepidation and many, many questions.
Readers could flood the phone lines with their personal experiences dealing with newly merged or acquired vendors. And unfortunately these experiences are not speculative or theoretical, as the benefits are. The problems range from confused sales presentations, as product decisions twist in the wind, to serious stumbles in product strategy. Those who are closest to the customer – salespeople and project managers – are usually the most likely to leave for a more stable environment or be let go if they are substandard. And while this may make sense to the vendors, it hurts their customers the most.
But the worst of the merger mania is the false hope it creates that things will be different – that vendor performance is somehow by definition improved by being bigger and acquiring additional talent. This has not proven to be true. Instead, the biggest complaint of clinical IT users is that the owners comes and go, but the problems remain: poor project management; poor product quality:
• The project managers change often, and the new ones are not well trained
• The software has a fatal performance error in some obscure but critical, unexpected spot in the workflow, and the fix is months in coming
• Data goes missing, or those easy ad hoc reports are rocket science after all
• Pricing seems irrational, mysterious, opaque, and by default therefore, too high.
It’s nearly 2009, and this performance is simply unacceptable. And at no time has a larger, or re-financed, company made a difference in these ongoing flaws. Indeed these flaws continue to be exhibited by all clinical IT companies across the spectrum of size, age, nominal experience, or self-proclaimed innovation.
The Ugly
In the Sergio Leone film of the same name, the “ugly” characters were not necessarily “bad,” and so too the results of these vendor mergers and acquisitions might be good but ugly, or ugly but good when the film ends.
What continues to be ugly is the project management skills of the software vendors. Why does this matter to a software vendor? If they can get the product out the door, so what? Ah, but most software in the clinical IT space is offered in “ASP” (application service provider) mode. ASP services create the steady revenue stream and customer dependencies that build attractive public companies. So while vendors always say they are ready to support customer in-house adoption of their software and vendor independence, they are actually loathe to see it happen.
Clinical research IT vendors really do seem to be understanding the software functionality part of their business (something not true in the 90’s), and if they just stayed software vendors, that would be fine. But they, like CROs and consulting companies, are all hungry for the outsourcing dollar, greatly encouraged by biopharma’s willingness to budget and spend those dollars. So the money is coming in way ahead of the skill development, and this is where it is really ugly. Software vendors have not had the time, understanding or inclination to build the clinical development skills or basic data management/trial management expertise to execute reliably. One has to wonder if they should back off of what they don’t really know and let the industry they serve do what they (presumably) know.
What Are You Going to Do About It?
As always, sponsors are intimately entwined with the good, the bad and the ugly. Sponsors need to become much more savvy about what to expect from, and how to manage and monitor, their software vendors. They need to think hard about the cost of outsourcing in all its dimensions (full-service, EDC study builds, CTMS report writing, ePRO logistics, and everything in between), and not just assume the benefits are captured in moving around budget line items.
Sponsors can help the newly merged or expanded vendors greatly. I have long argued that in the small world of eClinical information technology, sponsors need to pick vendors and nurture them, not just sit back and excoriate them when they fail. But as the years go by and the vendors continue to come and go, these choices of whom to nurture, and when, and why, and for what, become harder and more mission-critical.
As enterprise decisions get made, necessarily, by enterprise-level managers, the decisions, necessarily, are made that much farther away from the front lines. Executives and professional contract managers think they are signing on a CRO partner when they pick a software vendor, and decide on the basis of similar criteria (or should we say instincts, or platitudes?). Unfortunately, while clinical IT vendors may try to sell to pharma customers as if they were CROs, theirs is actually still a software business, with engineering on the inside, wrapped in a shell of a very special kind of project management. And so these vendors survive by seducing an unprepared level of decision-maker, sticking the operational staff with the consequences.
Of course the vendors also have much to account for. They should be doing much more about the effectiveness of their internal operations in management across the board, in project leadership skills, in honest and timely communication with their customers, and so on. Like most mergers in all industries, little time or money is spent on the critical need to evaluate staff skills and workflow processes carefully for the best in hand. Vendors shouldn’t brag about these ownership changes if they don’t really know what has happened to their product, staff, or service capabilities.
What should be clear to anyone making a decision based on this generation of newly merged or emerging vendors is this: bigger isn’t better, smaller isn’t better. Only better is better. It still remains a case of caveat emptor, and we emptors have a lot to be wary of.
We all know how important it is for clinical research organizations to have well-developed, clearly documented, standardized procedures (SOPs), with supporting technology, in order to conduct our business effectively. Despite SOPs often being derided, we don’t think anyone would disagree that these procedures and systems are a key part of ensuring that a sponsor’s clinical development and drug safety complies with regulatory and ICH requirements and standards. Equally importantly, SOPs and technology documentation serve as the backbone for training clinical research personnel, governing the day-to-day activities of each functional group within the organization.
Increased regulatory scrutiny (or the promise thereof) has further pushed the focus on SOPs, with information technology often playing a key role in facilitating and enabling this compliance. However, the interpretation of what “compliance” exactly requires can become lost in translation; the lengths to which some groups have gone to comply with regulations may become counterproductive, and at times even unnecessary. One might call it….obsessive.
Some clinical research groups make Herculean efforts to achieve a perceived level of quality in their work that, in the end, actually surpasses any true need or business benefit. In fact, rather than addressing a real need, adopting over-burdensome, unnecessary quality assurance procedures can actually create more problems by decreasing productivity, creativity and personal responsibility for quality work. Tied to that, of course, is the way that technology can be used (or mis-used) to enable this unhealthy focus on perfection. Indeed, information technology is often a prime forum for misplaced quality obsessions. Not only do quality assurance professionals often misunderstand the meaning of essential concepts of technology quality (like “systems validation” and “21 CFR 11 compliance”), but quality can be misused in ways which obstruct technology acquisition and implementation (and return on investment) without justification. Most disturbing of all is that IT professionals themselves, in some biopharmas, are witting accomplices to these misjudgments.
When bad things happen…
When you look at the SOPs that certain functional groups have developed, you can’t help but wonder if some event happened in the corporation’s “childhood” to make them almost obsessively concerned with achieving perfection – to avoid mistakes or errors at all costs. This past experience may trigger what we’re calling “Obsessive Quality Disorder”. Perhaps an organization can experience the same kind of reaction to a negative experience (for example, receipt of an FDA Notice of Violation or Warning Letter) as an individual or a family experiencing a life-changing trauma. The parallels can be instructive.
For an individual or a family, the reaction to a negative experience can take many forms. One example is when children revert to a younger stage of development in reaction to a family transition or crisis. For example, a family moves to a new town, leaving many friends behind. Immediately or shortly after the move, the four-year-old daughter starts to have temper tantrums, something she has not done since she was two. If parents are insecure, they will create more of a problem by becoming overly reactive and anxious. They might miss the obvious connection between the geographic move and the regression, and instead look needlessly for more complicated explanations and solutions.
In personal psychology, the problem can go further. The definition of Obsessive Compulsive Disorder (“OCD”) is when people have repeating doubts about whether a situation is safe. People with OCD respond by obsessing often about whether things are orderly and symmetrical. In order to reduce the anxiety that bad things my happen (again), someone with OCD will act in compulsive ways by creating rituals (“policies and procedures”) that are meant to keep the feared event at bay.
The parallel corporate behavior shows up in clinical development. For instance, clinical data management departments might respond to an auditor’s observed deficiency by putting elaborate, cumbersome procedures in place to guarantee this “traumatic event” (the observation) will never happen again. Departmental subgroups might be added to implement these processes, and organizational charts end up ballooning to accommodate a new workforce devoted to ensuring (obsessively) that no step in a given process will ever go unverified.
Drug safety departments in particular are susceptible to embracing highly-detailed, complex and redundant procedures that focus on ensuring “quality” (which they translate into “compliance”). It’s not unusual to find personnel in these groups spending an inordinate amount of their day checking, double-checking and sometimes triple-checking what someone has already done before them in the process, with no other justification than “assurance”.
If one is able to investigate the root cause of this behavior, the phrase you find that best summarizes things is: “we don’t trust them” – “them” being either another department, a subordinate, a partner company, or even the co-worker sitting in the next cubicle. This subliminal atmosphere of mistrust and pursuit of perfection can actually negatively affect individuals’ performance, when people are constantly in fear of being “caught” making an error.
This is also where “OQD” is most disruptive to technology innovation. Very expensive, resource-consuming clinical IT projects have been delayed for months or years because of the inherent mistrust we are describing. It is not technical design, vendor failings, or even resistance to change among users which ultimately delayed these projects, but rather an intractable mistrust based on equally well-meaning but dysfunctional motivations.
Road to recovery
When an organization has obsessively over-treated a problem, the first step to “recovery” is to recognize that a problem or unhealthy situation exists. Taking a big step back and re-examining a department’s process isn’t always an easy thing to do, especially when there is a set of beliefs about quality that has been deeply ingrained within the organization.
Equally difficult are situations where those in upper levels of management are not willing to re-consider that procedures are overly “quality burdened”. In these instances, a significant effort by correctly empowered personnel need to help upper management re-examine the big picture, and find the balance between responsibility and fear.
One way to find the right balance is to use the wisdom of the people who actually do the work to create the solutions, rather than imposing something on them from other departments or from on high. When solutions are co-developed with the people who carry them out, there is generally more buy-in and better outcomes. This is most dramatic when comparing the mindset of an auditor or even an IT department liaison to that of the actual user of the process or technology in real work.
Prevention is better than intervention
Healthy companies, like healthy families, are able to respond to problems in a secure, reflective way, looking at the strengths and abilities of the people and systems that are in place, capitalizing on them, and adding only practices which are necessary to perform correctly, or use their energy for innovation. Healthy personalities are willing to make changes, even dramatic ones, which are consistent with the end goals, but give up on short-term targets that are no longer useful.
Regularly re-examining your department’s approach to quality is important to ensure that some level of “Obsessive Quality Disorder” isn’t unnecessarily preventing IT innovation and other efficiency initiatives intended to improve compliant clinical research. A little family therapy can go a long way to helping your company’s productivity.