The need for efficient drug development, as well as advances in technology and medical research, have spurred the growth of the smaller, more focused contract research organizations. These smaller CROs may offer preclinical and early-stage clinical research services such as toxicology, process development, and small-scale manufacturing of clinical trial materials. They also may provide specialty services in a certain therapeutic field, a specific animal model, a particular R&D process, or a targeted technology. Niche CROs, experts say, can, at times, fill a service need that some of the larger organizations may not be able to provide. “There is an amazing number of facets to clinical research, and there are dozens of niches that need to be filled," says Mark Weinstein, CEO of BioClinica, which provides medical image management and other e-clinical services. “There is a wide spectrum of services required to make a successful drug submission. Drug development is not a generalist market; most of the specialization… Sidebar: Key Therapeutic Areas to Remain Drivers of CRO Growth KOLs and Specialty Markets Experts on this topic Graham Bunn, Ph.D. VP, Partnerships and Alliances, Medidata Solutions, a global provider of hosted ­clinical development solutions. For more information, visit mdsol.com, or e-mail [email protected]. Michael J. Butler, Ph.D. CEO, Xceleron, which provides bioanalytical accelerator mass spectrometry services for accelerated early drug development. For more information, visit xceleron.com. Edward Cox. VP, Corporate Development and Investor Relations, NexMed Inc., a specialty CRO providing in vitro and in vivo ­pharmacology services and research models. For more information, visit nexmed.com. Peter Derycz. Chairman and CEO of Derycz ­Scientific, which develops enterprise content ­management, workflow, and compliance ­solutions. For more information, visit deryczscientific.com. Tim Dietlin. VP, Alliance Development, INC Research, a CRO that ­provides customized Phase I through Phase IV programs in therapeutic areas of specialty. For more information, visit incresearch.com. Scott Dixon. VP, Global CRO Partnerships, Phase ­Forward, a provider of data solutions for clinical trials and drug safety. For more information, visit ­phaseforward.com. Michael J. Harte. Founder and President of the Harte Group, a functional services ­management organization. For more ­information, visit hartegroup.com. Thomas E. Hughes, Ph.D. President and CEO, Zafgen Inc., a biopharmaceutical ­company developing novel therapeutics to treat obesity. For more information, visit ­zafgen.com. Ron Jubin. Director, Research and ­Development, PBL InterferonSource, which offers a selection of interferon-related research solutions, including hard-to-find interferon-alpha ­subtypes from different animal species. For more­ ­information, visit interferonsource.com. Timothy C. Tyson. Chairman and CEO, Aptuit Inc., a contract development and manufacturing company. For more ­information, visit aptuit.com. Mark Weinstein. CEO, BioClinica Inc., a global provider of integrated, technology-enabled clinical trial management ­services. For more information, visit ­bioclinica.com. Gary K. Zammit, Ph.D. President and CEO, Clinilabs Inc., a contract research ­organization that provides early-phase and specialty clinical drug development services. For more information, visit clinilabs.com. n the past 12 to 18 months, many e-clinical technology solutions, including IVRS and IWRS, ePRO, imaging and EDC, have become more widely adopted within biopharmaceutical and CRO organizations. Peter Derycz, chairman and CEO of Derycz Scientific, says technologies are necessary to help companies centralize workflows — data, content, and documents — from the research to approval and postapproval phases. “As the world goes digital, it has become critical for pharmaceutical companies to harness the growing universe of information and make it all accessible at a moment’s notice," he says. “To this end, companies should source expert solutions and partners to assist in solving critical information challenges." Michael Harte, founder and president of the Harte Group, says the greatest impact will not come from newer technologies, but from focusing on making use of the technologies that exist today. “Currently, the market is filled with many existing and novel technology solutions for different applications that support data collection, however, the tendency is to continue to customize processes when ASCII and CSV file formats can be supported for interchanges," he says. “The industry continues to implement technologies without properly training those who use the tools, and we continue to introduce technologies without the input of those who use those tools. In addition, a great deal of focus is spent on back-end systems and global CTMS, while the root cause of poor data is ignored, which is a lack of support for those initially putting the data into the systems." Graham Bunn, Ph.D., VP, partnerships and alliances, at Medidata Solutions, says there are three different areas in which R&D technology solutions will have the most impact in the next five years. First, he says, the current, relatively stand-alone e-clinical technology solutions are becoming more integrated so that data — both patient data and study metadata — can come together to assist scientists in making intelligent, informed decisions about clinical trials. “For example, ePRO and IVR/IWR systems will be routinely feeding data into EDC systems, removing the need for multiple data entry and database reconciliation, while providing major opportunities to run safer clinical trials more efficiently," Dr. Bunn says. “Centralized reporting systems will provide more integrated views across all the e-clinical data around a clinical program to ensure all components are managed to obtain maximum return on R&D investment." The second trend is that technology solutions will, of necessity, move more upstream into the early phases of R&D planning. “The study protocol is still reliant on paper and dated technology such as Microsoft Word, yet it’s at the heart of every clinical trial," he says. “While it has been repeatedly shown, for example by the Tufts Center for the Study of Drug Development, that the complexity of clinical trials continues to grow, and while it is known that the protocol can have a huge impact on timeliness, cost, and patient recruitment, little has been done so far to resolve this situation. “Now, however, technology solutions have been developed to address this vitally important part of the R&D process and allow biopharmaceutical companies to develop smarter e-protocols that take advantage of corporate standards, include budgetary trial impacts and allow for the evaluation of study complexity and its likely impact on a trial," he continues. “Additionally, these e-protocols can capture the protocol information as text, making them human readable as well as simultaneously in standards such as XML and CDISC ODM so it can be readily stored, transformed, queried, reused, and shared with other e-clinical systems without the need for human interpretation." Dr. Bunn says a third trend will bring e-clinical data together and have end-to-end solutions from e-protocol design to study data delivery that share data standards, which will allow the biopharmaceutical industry to perform much better analytics around the clinical trial process. “Lessons learned can provide feedback into the planning process to improve the quality, cost-effectiveness, and timeliness of clinical trials as well as provide input into the predictive modeling and forecasting of R&D programs in the future," he says. Scott Dixon, VP of global partnerships at Phase Forward, says technology is impacting all facets of R&D — from finding and enrolling patients, to subject randomization, data collection, safety reporting, and analysis and submission. “The real impact will be tying this technology together," he says. “An integrated suite of software that can automate the management of the entire clinical process and link data to the downstream analysis and reporting processes will give better control to study management and help realize new R&D efficiencies." For example, Mr. Derycz says in response to the FDA’s mandate in 2008 to adhere to the electronic common technical document (eCTD) format for electronic regulatory submissions, a pharmaceutical company should find an eCTD software provider that can scale to meet its needs, plus a professional document repurposing company whose expertise lies in document retrieval and formatting. F PharmaVOICE welcomes comments about this article. E-mail us at [email protected]. A pharmaceutical company should find an eCTD software provider that can scale to meet its needs. Peter Derycz The industry continues to implement ­technologies without properly training those who use the tools. Michael Harte Technology solutions will, of necessity, move more upstream into the early phases of R&D planning. Dr. Graham Bunn CROs: Technology Trends

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