Biometrics services (data management, biostatistics, data standards, and statistical programming) can be outsourced together as a unit or individually with different CRO partners. While splitting services up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the data management and biostatistical/programming components for your clinical trial project or program.
When one CRO provides both data management and biostatistics/programming services for a trial, you can benefit in the following ways:
1) Well-designed database and less re-work
Data management, data standards and biostatistical experts collaborate from the earliest stages of study start-up. Early collaboration on CRF design, clinical database set-up, and the clinical data validation plan ensures that the clinical data will support your trial endpoints, CDISC standards are applied, and reduces the potential for costly statistical and programming re-work associated with a poorly designed database.
2) Cleaner data
When biometrics services are provided by the same company it leads to three functional areas working toward the common goal of minimizing data errors. In addition to the standard checks data management provides, statistical programmers and biostatisticians are communicating errors identified through routine programming and Pinnacle 21 CDISC conformance checks. These groups seamlessly work together to identify and resolve errors without having the Sponsor facilitate communication between the data management and biostatistical vendor.
3) Better traceability of data and potentially faster approval
As data managers, data standards experts, and biostatisticians collaborate early in the clinical trial process, they are able to focus on creating clinical, SDTM, and ADaM databases in a manner that amplifies the traceability of data. Planning for the use of CDASH, SDTM, and ADaM standards from the start will increase traceability, facilitate FDA review, and potentially expedite approval timelines.
4) Faster timelines
Standards can be leveraged to expedite timelines when all services are within a single company. Data management maintains a standard library of CDASH-compliant case report forms that both shorten EDC build times and expedite the transformation into SDTM. When these services are spread across different CROs these efficiencies and standards no longer apply as different CROs maintain their own libraries.
As you evaluate your biometrics needs, consider selecting a CRO with a steep legacy of proven biometrics expertise who will provide you with the right strategies necessary to advance your product development program efficiently and completely.
Heather Kopetskie, Senior Director, Biostatistics, has worked at Rho for more than 19 years. Ms. Kopetskie provides leadership and oversight for the biostatistics department and utilizes her experience to guide sponsors on the design and analysis of clinical trials. Her experience spans many therapeutic areas with an emphasis on solid organ and cell transplantation along with rare disease (orphan) products. Ms. Kopetskie has supported both federally funded projects and biotech/pharmaceutical companies. She has served as the biostatistical functional lead for the Immune Tolerance Network (ITN) Statistical and Data Coordinating Center and the Clinical Trials in Organ Transplantation (CTOT) Statistical and Clinical Coordinating Center overseeing more than 30 studies in the areas of allergy, immunology, and transplantation.