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CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 16 leaders ROUNDTABLE Frequently the large CROs are often undifferentiated (no distinguishing fea- tures) and inconsistent (great experience one trial, terrible experience the next). The reality is that CRO excellence does not vary as much at the company level as it does at the individual project team level. At Pharmacia and Wyeth, we found that by defining a superior system, training people on that system, and being rigorous in the training and selection of project managers (and culling those project man- agers who cannot perform at a high level), it is possible to create a dominant organi- zation. Turf, habit, and the buddy system are the enemies of first-rate performance. CROs are well-positioned to capital- ize on information technology requiring increased standardization. I can see the CROs moving into direct access of patient data from electronic medical records and testing systems, as long as the data exists in a uniform format globally. The CRO systems will evolve to manage massive amounts of information in validated envi- ronments. CROs are more likely to develop this capability than individual pharma companies. CROs of the future will be operating in different business models compared to today (see above), becoming stronger stra- tegic partners with sponsors. They will be fully integrated into team structures and will have accountability for delivering on a program with objectives and rewards similar to sponsor team members (i.e. much less transactional and much more strategic and program-oriented). In your opinion, what are the key CRO attributes companies should be assessing today to successfully execute clinical trials of the future? Number one now and for the foresee- able future is the specific team of people who will be executing your trial. Number two is the sophistication of their systems and their ability to reduce the costs of sub- sequent trials by not duplicating the work done on the current trial (e.g. by using standard data management elements or formats). Number three is the ability to conduct trials in the regions most perti- nent to commercially important approv- trouble engaging in the clinical research enterprise. Combining new community- based models with disruptive technolo- gies (eSourcing, eConsent, EMRs, Web- based approaches) has the potential to dramatically transform clinical research and put it back on a path to efficiency, suc- cess, and productivity. What do you envision as being the biggest opportunities (e.g. social media) for conducting clinical tri- als of the future, and how should companies capitalize on these opportunities? At this time, the percent of the popu- lation with any given disease condition participating in a clinical trial is quite low — typically around a few percent. Social media, broadly speaking, is an important and underutilized means of educating and reaching potential trial participants. I have become a fan of crowdsourcing. As the pharma industry moves toward greater transparency, it opens the door for greater input from the full spectrum of custom- ers (investigators, researchers, patients, advocates). Many companies are posting a protocol synopsis for general comment from interested parties, and the results have been stunning in terms of improving the study. Also, new productive investiga- tors have been found among those who are motivated to connect and comment. Web-based and social media approaches to identifying the right patients for clini- cal trials, especially in remote settings not currently accessed by traditional methods, would help to overcome recruitment woes. EMR (electronic medical record)-embed- ded electronic flags to providers are already being tested successfully in identifying potential trial candidates. Electronic con- sent is being used in some trials as a way to access new patients and facilitate their participation in clinical trials. Electronic sourcing will overcome the redundancies and inaccuracies involved in paper-based source documents, and it will enable real- time data monitoring to improve trial exe- cution and ensure patient safety. How do you think CROs of the future will differ from how they look today, and why? als, not just now, but at the time your compound is improved. CROs must be the early adopters of emerging technology, novel approaches, and new concepts, which represents an interesting parallel. In the same way many larger pharma/biotech companies have enhanced their portfolios by acquiring small, novel discovery companies, CROs will make similar advances and innovations by acquiring small specialty or niche CROs. Sponsors should look for demonstrated expertise in adaptive design, risk-based monitoring, and codevelopment of biomarkers/diagnostics and drug products. CROs will need to build their talent pipeline with the skillsets that support new operating models, with greater stra- tegic and technical expertise, collabora- tive mindsets, and flexibility to work in diverse environments. And leadership will need to be open to alternative partner- ship arrangements that are tailored to the needs of their customers. What tools and/or metrics have you found to be the best for effec- tively assessing these attributes, and why? There is no alternative to dealing with the issues in detail. Interview the perti- nent CRO staff with detailed technical questions of how they recognize and deal with problems. Also assess nonverbal fac- tors such as emotional intelligence and drive for results. Ask about rewards for retaining key staff and what punishments are in place for losing them. Of course, you should also look for industry-standard information systems. Successful uses of the attributes I describe are relatively easy to assess through the data. For example, adaptive design requires quick turnaround of data and the ability to make seamless enroll- ment adjustments without a negative impact to timelines. True risk-based moni- toring yields variable-monitor resource utilization and quality improvement, which are also visible in the metrics. It's also important to assess the rate of acceptance of submissions to regulatory authorities. It is fine for a CRO to claim THE FUTURE OF CLINICAL TRIALS IN AN OUTSOURCED MODEL By R. Wright 0 3 1 4 _ C R O _ R o u n d t a b l e _ F u t u r e 3 C . i n d d 5 0314_CRO_Roundtable_Future3C.indd 5 2 / 1 9 / 2 0 1 4 1 : 4 5 : 1 4 P M 2/19/2014 1:45:14 PM

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