Biostatistics and Data Management Key to Clinical Trials
Biostatistical Analysis and Data Management Support Key to Success of Complex Clinical Trials
The Biostatistics team at BioPharma Services will help to get the right outcomes to your clinical trials. Our Team offers much more than statistical analysis. We will assist in optimizing your protocol, providing expertise in the design of your study, and expert SDTM and AdaM creation. A well-designed statistical analysis plan and robust evaluation of clinical trial outcomes become especially important in the context of progressively complex clinical trials. At BioPharma Services, a team of talented and experienced biostatisticians, programmers, and data managers provide support to clients conducting studies in our Clinic, as well as to Sponsor companies requiring dataset analysis of external studies. BioPharma’s global Statistical Team can be tailored to meet your study needs,
Statistics plays an essential role in all clinical trial stages,[i,ii] and BioPharma’s team of statisticians provides excellent support throughout the complete study duration. We accelerate decision-making through robust clinical trial design and protocol development help to reduce/eliminate any potential study bias. As a full-service clinical research organization committed to delivering excellence in early-stage clinical research, BioPharma has developed a full suite of clinical solutions, including statistical support, for Phase 1 to bioequivalence/bioavailability studies to assist clients’ clinical drug development programs. We are proud of our team of experienced biostatisticians and programmers and believe that we have the most qualified biostatistical team of a Canadian CRO.
Clinical and Statistical Solutions for Human Abuse Potential Studies
BioPharma also differentiates itself through its expertise and clinical solutions in another area, namely Human Abuse Potential (HAP) studies. Our core Scientific team and Statistical staff have extensive experience in all essential areas necessary for executing HAP studies, bolstering pharmacy expertise in the analysis of these trials. In addition to controlled substance licenses at our Canadian and U.S. clinical facilities, we have extensive experience with all classes of Central Nervous System (CNS) compounds, including analgesics, antidepressants, stimulants, anesthetics, and anticonvulsants. We also have insight into the regulatory requirements for HAP studies, enabling us to provide statistical support optimally aligned with regulatory guidance.
BioPharma’s Data Management Services
Clinical Trial Data Management is critical for the generation of high-quality clinical trial data in a timely manner.[iii] BioPharma Services’ biostatistical and data management teams collaborate to ensure that data are managed correctly through all clinical trial stages, and a comprehensive Clinical Trial Data Management plan (DMP) is developed. Our onsite Phase I Clinical Trial Data Management team has expertise in Electronic Case Reform Form (eCRF) design and development, customized clinical data management programming, third-party data integration, query management, safety data management and reconciliation, data export/transfer, database closeout and delivery, serious adverse event (SAE) reconciliation, and interim analysis readiness. In addition, we have expertise in the collection and review of pharmacodynamics data.
BioPharma’s CDISC Data Conversion Services
Conversion of clinical and metadata to comply with the Clinical Data Interchange Standards Consortium (CDISC) ensures compliance with regulatory requirements and streamlines the review process.[iv] We support our clients with dataset mapping under Study Data Tabulation Model (SDTM) standards and CDISC conversion. Our team has expertise in creating SDTM annotated CRFs, SDTM datasets, ADaM analysis datasets, pooled analysis datasets (ISS/ISE), and data handling reports.
[i]Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018;11:156-164. doi: 10.1016/j.conctc.2018.08.001.
[ii]Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337-2343. doi: 10.1001/jama.2017.18556.
[iii]Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: An overview. Indian J Pharmacol. 2012;44(2):168-172. doi: 10.4103/0253-7613.93842.
[iv]Gaddale JR. Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management. Perspect Clin Res. 2015;6(4):179-183. doi: 10.4103/2229-3485.167101
About BioPharma Services
BioPharma Services, Inc., a Think Research Corporation company, is a full-service Contract Research Organization (CRO) based in Toronto, Canada, specializing in Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.