Biopharma executives regularly face a series of decisions beyond their original professional competency. This is a requirement for biopharma executives’ success and I imagine therein lies much of the appeal of the job. In all 21st century management, decisions are accompanied by choices in the use of information technology, and this is no less true in biopharma clinical development. This supplement covers a sampling of the myriad issues in using IT to support the process of human testing of new drugs.

IT decisions should be like any other decisions you are making – they must first be cast in the mold of your business strategy and business conditions. Both strategy and conditions vary widely from company to company, even when the companies may seem so similar in purpose and objectives. (This is why “benchmarking” is so dangerous.) As these circumstances vary, so do the parameters upon which IT decisions must be based. The issues are different and so too are the resolutions, depending on how your company is funded, staffed, experienced, pipelined, partnered, organized and led. Indeed, IT is entwined with company strategy and business conditions in a Gordian Knot of inseparable implications.

Biopharma execs are often impeded by their own backgrounds – commonly either academic or laboratory-based. Clinical research is unfamiliar territory and may appear to be misleadingly “simple” compared to bench science and the “genius of discovery”. While the cry of “eureka!” may be hard to hear during the long years of clinical trials, the science and rigor in clinical research are no less important to bringing a discovery into medical practice. So the first challenge for biopharma execs is to put the right people in charge of clinical development – those who understand and respect it. It may seem odd, but this is the first step to effective use of IT in clinical research.

Decision, decisions; Choices, choices

Managing IT for any purpose encompasses infrastructure, platforms (hardware/software), networking and security, quality management and validation, user support and maintenance, and the software applications which your staff actually use. In clinical development, there is a wide range of applications which can be employed, and for which a biopharma must determine which of these it really needs and when. A sampling of such applications include:

• Data handling (EDC, ePRO, CDMS)

• Trial conduct (CTMS, IVRS, study portals)

• Safety surveillance and reporting (AES)

• Submission preparation (submission manufacturing systems)

• “Infrastructure” (document management, data warehouse).

Too many biopharmas jump right into this list, like do-it-yourselfers at a big-box hardware store, and start watching vendor demos and freaking out at the price tags. The place to start instead is the business strategy: how are you going to run clinical trials, when, and why?

The first constellation of choices revolves around how you will resource your clinical development. Are you going to outsource most or all of the functions (a common approach for young companies)? Are you going to selectively outsource by function (keep data management in house but outsource site monitoring, or vice versa?), and what about project management? If you choose to operate functions internally, are you staffed appropriately? Are you willing to bear the cost and maintenance of these staff? Can you find the staff you need?

What do your partners use in the way of IT? Most biopharmas have all kinds of partners — companies you are licensing to, licensing from, using for key development services (radiographic readings, core labs, patient recruitment, clinical supply packaging), and so on. Do your partners offer technology systems you can leverage, or do you have a more efficient strategy? How do you pull together these multiple sources of data?

And where is your business at this moment, or next year, or in five years? Are you heading for submission? Quickly? Ever?

Each of these questions, each of these choices, dramatically alter the appropriateness, ROI and operational impact of any particular clinical IT application choice. Ultimately it comes down to a practical, essential business question: how do you control your clinical development process? And some executives would add, how do I have control and flexibility simultaneously? How do I have both rigor (compliance) and the creativity of entrepreneurial nimbleness? And of course, how do I do this on a limited budget?

Three Areas to Focus On

It is probably helpful for a biopharma executive to focus at first on three main areas of clinical research IT, what I will call control, product data, and safety.

Control, in this context, means knowing how your trial(s) — not your subjects or your product — are doing: are they on time, on budget, experiencing bottlenecks? Are they experiencing site performance issues, compliance issues, supply issues? Are your partners performing as expected? What changes need to be made? These questions are naturals for IT support. In the pharma world the application used is some kind of CTMS (clinical trials management system). Often, small young companies will avoid this arena, because the best known applications are big and expensive, and the small ones may not be robust or mature enough, or may have been developed for a customer’s situation too dissimilar from your own.

But in our experience, obtaining control over clinical trial conduct through information is as important, or may be more so, to a young company than the traditional focus on patient data handling. What is particularly challenging, besides the complexity of managing information from diverse partner data sources, is that the design for the kind of system your company needs must come from your clinical staff (not data managers or IT staff), and your clinical staff may be your least pharma-experienced.

I use the term product data handling to be as generic as possible in referring to your patient/subject data as it relates to the effects of your product (drug, biologic, device, combination thereof). This encompasses traditional CRF data, but these days increasingly includes relevant “non-clinical” data, PRO data (“patient-reported outcomes”), images (radiographic, pictorial, motion video), and more. This is often where a biopharma starts its clinical IT journey, particularly since this is where people with “data” in their title seem to reside, and where most executives are more willing to spend dollars on technology.

Handling product data for all biopharmas is increasingly focused on usability – both for the end user (the site) and the business (i.e., for accelerated decision-making). This means access, rapid startup, and ease of reporting. When seeking to control and analyze product data, it is harder and harder in 2007 to accept a paper-based, backend-heavy application strategy. Thus a traditional CDMS gets hard to justify, especially considering the time to start up and staff the necessary support, and to run the accompanying paper processing. But are newer approaches (EDC plus an analytical backend, versus a storage-oriented backend) too risky for a new company? These newer approaches may be actually more appropriate for a new company: a) they are easier to implement in a “blank slate” environment; and b) the risk, such as it exists, is likely to be more than offset by timely data and the facilitation of interim analyses. Regardless, a number of critical staffing, process and infrastructure decisions have to be made to implement an effective data handling approach. Again, a business’ priorities should guide these choices.

Conservatism finds a home in young biopharmas when considering the monitoring and reporting of patient safety. Fortunately, a handful of similar software applications are available to choose from in this area, and because the number of your staff who will be using them is likely to be small, the cost of these applications are quite reasonable. Here the choices are much easier: pick an application, buy it and use it. Complex resourcing algorithms are not necessary; ROI pales in comparison to the cost of a safety crisis.

Nonetheless it is surprising how often biopharma executives (who have the most to lose, personally and professionally, by a safety crisis) will balk at the cost and perceived complexity of owning a safety monitoring and reporting tool. This is particularly ironic for those companies who are counting on multiple indications for their compound or biologic, and must have the means to detect safety indicators across the development stream to ensure an acceptable safety profile. Once again, the business strategy and the supporting IT needs are intertwined.

Just a Taste

This overview of control, product data, and safety is just the beginning of the IT issues which require decisions in support of clinical development. There is much else to consider, including where and how you equip your infrastructure, on what platforms, under appropriate quality management systems and with compliant validation. The key is that biopharma executives should not abdicate their involvement in these decisions because the issues seem too technical or too narrow. Precisely because of their inextricable connection to the business decisions executives are responsible for, clinical IT choices must be made with the help of senior management.

Innumerable issues must be considered and resolved as you prioritize your IT needs, schedule IT adoption, select your vendors and shoulder the mighty work of implementing these tools with your staff (or new staff), under the correct governance model, with efficiency, flexibility and compliance. Trying to cut through the Gordian Knot will lead to your operations falling in pieces. Embrace the conundrum and you will learn much about the complexity of clinical development, and through such learning will come excellence in biopharma leadership.