2018 Biotechnology Awards

44 GHP / Biotechnology Awards 2018 , BI180005 Best Multi-Speciality Clinical Research Network 2018 - USA PinnacleTrials, Inc. ® is amulti-specialty sitenetwork for clinical research.We invitedRobert Robbins, Clinical ResearchDirector, to talkus through thefirmand the range of services it provides. Established in 2001, Pinnacle Trials, Inc. ® offers research expertise and centralized services to sponsors and contract research organizations. Located in Atlanta, Georgia, the firm is fortunate to have a diverse subject population. Robert, who won the 2016 Clinical Researcher of the Year (CROY) Award, draws on a wealth of experience in the field, has been ACRP certified for 17 years and IATA certified for 13 years. Robert discusses the firm’s service offering in more detail and outlines how he has helped drive it to the success it enjoys today. “I am proud of my contributions to the medical and scientific communities over the last twenty-two years. I have made Pinnacle Trials my home since 2001 where I play a vital role in patient safety, good documentation practices, quality assurance, staff training, and business development. For me, winning the GHP and CROY awards are personal acknowledgments of my lifetime commitment and dedication to my study volunteers. Most importantly, I am honoured to represent Clinical Research Professionals’ hard work and pivotal contributions to the drug development process. I take great joy in helping bring new medications to the market faster.” “What makes Pinnacle Trials different is our systemization, attention to detail, and quality control for each protocol’s distinct step-by-step process and procedures. Patient safety is our priority. We take exceptional care of our study volunteers and thus we have high enrolment and strong retention rates. Furthermore, we understand the importance for our sites to quickly and efficiently report findings to Sponsors, and the need for Sponsors to have safety data readily accessible for remote viewing in real time. This is especially important if the Sponsor has scheduled an interim analysis or safety committee meeting. Therefore, we are available to our CRAs and medical monitors for risk- based monitoring at a moment’s notice. This means that being available not just to the patients, but to the Sponsors and CROs 24/7, is a vital component of our company.” Drawing on his vast experience in the industry, Robert has seen many changes over the years, and he is keen to detail how these have affected his leadership of Pinnacle Trials, Inc . ® “Over the past twenty-two years I have seen many changes in our industry including more stringent study entrance criteria, additional protocol screening and follow-up procedures, and use of multiple electronic portals for data entry, IP management, and reporting adverse events of special interest. These changes increase the need for ongoing staff training to meet current protocol demands. When I first started conducting research the industry standard was one ECG at the beginning and end of each study; now a protocol can have multiple ECGs taken throughout a single visit. In the past, typically one X-Ray of the knee was required at the screening visit of an osteoarthritis study; now X-Rays and MRIs of multiple joints are captured throughout several protocol specified timepoints. This intensifies the demand on both the study staff and patient volunteers. Protocol adherence and thoroughly developed source documents are critical in meeting today’s challenges. We ensure that our documentation is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+CCEA).” Fundamentally, Pinnacle Trials, Inc. ® is committed to providing the most efficient, informative, and accurate clinical trial resources available. From recruitment to trial management to data collection, Pinnacle Trials focuses on patient safety, patient qualification, strict adherence to FDA regulations and ICH guidelines and impeccable documentation, as Robert continues. “While detailed source documentation is crucial, so is documentation of the processes of staff training and equipment calibration. Our equipment is routinely Serviced, Maintained, Available, and Calibrated (SMAC). This equipment includes our centrifuges, ECG machines, BP cuffs, X-Ray, MRI, ultrasound, nerve conduction velocity equipment, and thermometers. Following the National Institutes of Standards and Technology (NIST) criteria guarantees the integrity of our investigational products. Our study medication is electronically monitored 24/7 with NIST calibrated data-loggers.” “Documented competency training is critical to implement Photo: Robert Robbins,Clinical Research Director