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Finding Efficiency in Clinical Research

If you are not locking your database within 5 days after your “last subject is out” then something is wrong.

 

It is a well-recognized in clinical research that succeeding and/or failing quickly is critical to the ability to bring new therapies to market. There are many aspects of clinical research that are beyond our control, such as how will the drug compete against other therapies in efficacy, how will the drug interact with the physiology of the subjects, and will this yield a favorable safety profile? These are the questions we hope to answer by conducting clinical trials, but we don’t have any direct control over them until we get the data.

 

What we do have control over, is how we collect and analyze the data, and more importantly, how quickly we are able to obtain this data to arrive at that critical and expensive decision of whether or not to proceed further. Over many years working in the biopharma research industry, I notice how much discussion is spent on getting that first subject into the trial. But many would argue that a heavier focus should be placed on getting the trial completed, so that you have the data you need to make critical development decisions. The database lock timepoint, then, is the key step in arriving at a development go/no go decision.

 

I continue to be shocked when I ask at conferences and clients, “How many days, on average, after last patient out, do you lock your database?” and the responses are overwhelmingly “weeks to months”. There are those few companies that are doing this within 5 days, and to those I say congratulations! ­– you need not read any further. To the rest, if you are using electronic data capture (EDC) and you are not locking your database within 5 days of last subject out, then there is something broken in your process. This applies to both outsourced and insourced models, and to a large degree is independent of the EDC software you are using. To be fair, some software solutions may make this process a little easier with various built-in tools, but most of you can achieve this goal with your current EDC technologies.

So, you should ask yourselves about whether your procedures are preventing you from completing your trials in an expedited fashion; this is one of those components of clinical research that you have full control over, and there are many proven strategies and techniques to succeed at faster database lock processes. Often, as in most process analysis and correction, the solution is very specific to your particular circumstances of talent, policies, politics, compliance and history. If you are interested in updating your processes to take full advantage of the technology you have purchased and implemented, then please reach out to Waife & Associates at www.waife.com. Or to me directly at shevel@waife.com. We have a proven track record over 25 years specializing in biopharma clinical development to address these types of issues. A 5-day database lock is a very real and achievable milestone, and if you are not achieving this performance in your Phase II and Phase III programs, then you are leaving opportunities and money on the table.

Needham, MA, June 8, 2017– The fourth annual Benjamin and Sholom Waife Memorial Scholarship in Scientific Journalism was awarded at Needham, Mass. High School Class Day ceremonies this Spring. The scholarship, created by Waife & Associates, Inc., supports collegiate studies toward a career in writing or journalism about science and medicine. The annual award’s recipient this year is Audrey Wey Pratt, selected by the faculty of Needham High School.

The Scholarship is in memory of Benjamin Waife (1895-1972) and his son Sholom O. Waife, MD (1919-2011). Waife & Associates, Inc. is based in Needham and was founded by Dr. Waife’s son, Ronald S. Waife. Benjamin Waife, writing under the pen name B. Z. Goldberg, was a newspaper editor and columnist for over fifty years for New York and Israeli newspapers. For much of his career he was managing editor of Der Tog, one of the two main Yiddish newspapers in New York City in the 20th century. He earned one of the first psychology PhD’s from Columbia and wrote two books, in addition to his weekly column which appeared in various newspapers until his death.

Dr. Sholom Waife continued the family writing heritage by combining it with his medical profession. He started one of the first in-service hospital CME Programs, at Philadelphia General Hospital, developed an award-winning series of textbooks while at Eli Lilly & Co. which were distributed to all US medical school graduates, wrote a column for the Physicians Bulletin, co-founded the American Journal of Clinical Nutrition, and was an early national officer of the American Medical Writers Association (AMWA).

Both Benjamin and Sholom Waife dedicated their professional lives to clarity in writing and using the written word to make complex subjects easier to comprehend. The Scholarship is intended to further these principles, in these times when science and medicine are increasingly affecting our daily lives, yet are moving further from common understanding.

Waife & Associates, Inc. awards this scholarship annually. The company provides management consulting services to biopharma organizations conducting clinical research.

April 5, 2017 – Steve Shevel, Senior Associate at Waife & Associates, Inc., will be organizing and chairing the Session on Optimal Use of Today’s Data Management Tools when Monitoring a Clinical Site, to be presented at the Annual Conference of the Society for Clinical Data Management (SCDM) in Orlando, Florida, September 24-27, 2017. Steve will also be presenting on the topic in the Session, which will include speakers from industry, investigators, and service providers.

 

Waife & Associates is a long-time supporter of the SCDM and its activities, including sponsorship of the Annual Poster Sessions and other support.

 

About Waife & Associates, Inc.

Waife & Associates, Inc. was established in 1993 to help clinical research companies build competitive advantage through process improvement and technology adoption. Headquartered in Boston, it works from offices in the US and Europe to apply senior domain expertise for pragmatic solutions to common clinical development operations challenges. For more information, please visit http://www.waife.com.

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San Diego, CA-(September 12, 2016) – Waife & Associates, management consultants for clinical research, sponsored the Poster Session at the Society for Clinical Data Management Annual Conference this week. Senior Associate Steve Shevel was on-hand to present the awards for best Posters to the following winners:

First Place: Jaskiran Singh, NIH

Second Place: Mary Williams, Duke

Third Place: Maria Fernanda Valverde da Silva, Gilead

“It is a pleasure to personally present these awards to the outstanding work of these data management professionals,” said Steve. “Waife & Associates has been sponsoring these Awards since their inception as one contribution to the development of the data management community and its professional standing.”   

 

About Waife & Associates, Inc.

Waife & Associates, Inc. was established in 1993 to help clinical research companies build competitive advantage through process improvement and technology adoption. Headquartered in MA, U.S., it applies senior domain expertise to provide pragmatic solutions to common operations challenges. For more info, visit http://www.waife.com/

FREMONT, CA-(Pharma Tech Outlook- Jun 15, 2016) – Waife & Associates, today announced that it has been recognized by Pharma Tech Outlook for Top 10 Clinical Data Management Solution Providers 2016.

Pharma Tech Outlook features its ‘Top 10 Clinical Data Management Solution Providers’ list annually in recognition of the top tech organizations helping business around the world. A variety of subjective and objective criteria were used for choosing the winners. Waife & Associates specializes in biopharma clinical research, process consulting in clinical research, information technology implementation (EDC, CTMS, AES, EDMS, etc.), and change management.

“It is a great honor to announce Waife & Associates, Inc. as one among the Top 10 Clinical Data Management Solution Providers 2016,” said Stacey Smith, Managing Editor of Pharma Tech Outlook “Waife & Associates has been making great strides in the clinical data management arena and demonstrates its prowess in helping clinical research organizations and pharmaceutical industries to make better decisions.”  

About Pharma Tech Outlook

Published from Fremont, California, Pharma Tech Outlook is a print magazine that covers most important and latest developments in pharmaceutical industries. A distinguished panel comprising of top IT decision makers, CIOs and CTOs from the pharma and life sciences industry, as well as the Pharma Tech Outlook editorial board finalized the ‘Top 10 Clinical Data Management Solution Providers 2016’ in the U.S. and shortlisted the best vendors and consultants. For more info: http://www.pharmatechoutlook.com/

About Waife & Associates, Inc.

Waife & Associates, Inc. was established in 1993 to help clinical research companies build competitive advantage through process improvement and technology adoption. Headquartered in MA, U.S., it applies senior domain expertise to provide pragmatic solutions to common operations challenges. For more info, visit http://www.waife.com/