Dave Li, MD, PhD, and Anna Baran, MD, KCR Consulting Validating the regulatory expectations on evidential requirements for predictive biomarkers is not a trivial process, but quite conceptually challenging. …

Doug Bain, Chief Technology Officer at KCR Bess Bess Stillman, M.D. has written a series of articles that describe the challenges that she faces with her husband Jake Seliger in finding a treatment for an aggressive form of Head and Neck Cancer that Jake has. I encourage anyone that is…

Anna Baran, MD, KCR Consulting The European Society of Medical Oncology hosted its annual ESMO Congress in Madrid Spain last week, from October 20–24, 2023. This year’s ESMO congress included a comprehensive educational and scientific program in the field of medical oncology that focused on innovative therapeutics and presentations of…

Anna Guildford, PhD | Senior Consultant, KCR Consulting The demand for medical writing is constant, as sophisticated clinical documentation is required beginning with pre-clinical documentation all the way to post-trial marketing materials. …

KCR Data Science & Documentation KCR had another wonderful experience attending Veeva Summit. Three representatives from KCR’s data management team joined thousands of clinical research colleagues in Boston to hear industry leaders speak about the future of clinical tech innovation. The two-day event covered a lot of ground, and the…

KCR Chief Technology Officer, Doug Bain For over 25 years, EDC vendors have provided the means for investigators to electronically sign eCRFs within an EDC system to say that they confirm the integrity of the data that has been entered. The need to do this dates back to before EDC…

Gene therapy clinical trials are increasingly complex and challenging. Understanding two of the biggest hurdles: patient recruitment and manufacturing costs, can help companies avoid potential pitfalls. Patient Recruitment Patient recruitment for genetic therapy product clinical trials presents a significant problem. Current gene therapy products often target rare diseases or specific genetic risk…

KCR Consultant, Zaneta Szkarlat, PhD and KCR Principal Consultant, Dave Li MD, PhD. Selecting appropriate sites is one of the most crucial factors for determining successful completion of a clinical trial. It is important to ensure that potential trial sites have the capability to meet the protocol requirements and the…

Medical Director, Piotr Piotrowski has spent nearly nine years with KCR. He has decided to pursue his career further as a researcher, but before he leaves, we got the opportunity to sit down with Piotr for an interview about his experiences and to reflect on the growth, challenges and relationships…