Trial Design, Management and Analysis

Whether it be an RCT testing the efficacy of a new drug or procedure, an observational study to monitor longer term disease progression and outcomes, a patient or disease registry to monitor utilization and long term outcomes, a pragmatic effectiveness trial to observe how a technology works in the ‘real world’, assistance with electronic data capture and management or analysis of trial, registry or outcome data, PATH can provide a vast range of expertise and infrastructure support to enable and conduct these studies.  

We have a designated clinical trial team to assist in forming testable research questions, in planning study designs, in developing study synopses to facilitate discussions amongst investigators and key stake holders, and in developing detailed study protocols outlining the study background, design, methodology, outcome measures, sites and sample size calculations, and overall study management, organization and analysis plan. Our clinical trial team has decades of experience in developing study Case Report Forms (CRFs) and have efficient strategies to help simplify and streamline data collection. A number of data collection and entry options are available to accommodate sites participating in the trial ranging from tradition paper CRF, to data fax forms to completely web-based electronic data capture and entry systems that reduce data queries and the necessity for double or triple data entry processes. PATH has developed a comprehensive set of Standard Operating Procedures (SOPs) to ensure consistency and the highest possible standards during all aspects of designing and conducting the trial and in analyzing and interpreting the trial results.

Our statisticians are experienced at developing detailed Statistical Analyses Plans (SAPs) for the studies conducted by PATH and have a long track record of providing consultation support for a wide range of different study designs and disease areas. Similarly, our contracts and legal team are very experienced at finding ways to expedite the often lengthy contract development and negotiation stage of studies and ensuring studies meet the increasingly complex and detailed requirements of oversight regulatory agencies and each institution’s REB.