The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical trial as an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial. ICH-GCP lists more than 60 separate responsibilities for the Sponsor1. The benefits of outsourcing clinical development activities have been well-known for many years and are the underlying reason for the vast expansion of the clinical research organization (CRO) industry in the 2010s. Indeed, ICH- GCP allows for the use of CRO services by Sponsors, but emphasizes that ultimately, the responsibility remains with the Sponsor. The range of responsibilities is wide, some of which is specified as the selection and recruitment of appropriately qualified personnel to perform all trial-related activities.
Of the Sponsor responsibilities defined by ICH-GCP, a large proportion has to do with clinical operations. The rest of the Sponsor responsibilities revolve around the collection, management, analysis and reporting of clinical-study and clinical-development-program data. Outsourcing of activities to fulfil these responsibilities can take many forms.
Phase I clinical pharmacology studies are many times conducted in specialized centers that function as closed clinical-study units. Those units recruit participants, conduct the study, collect and analyze the data and write the study reports.
As the product advances through its phases of development, the studies become complex in a way that is product- and indication-specific. Thus, each development program requires a unique set of solutions. From Phase I/II and onwards, the Sponsor, as the expert on the product and the indication/s, has to assume a more hands-on role in the design, conduct, oversight and analysis of results of clinical studies. While Sponsor responsibilities in the realms of clinical operations are within the expertise of specialized CROs, data-focused CROs can offer holistic solutions for the fulfillment of all other ICH-GCP defined Sponsor responsibilities.
A data-focused CRO is a multi-disciplinary team of experts that offer services in clinical data management, biostatistics, pharmacometrics, clinical programming, medical writing and pharmacovigilance. Such a team offers the benefits of experience and expertise that are potentially not-feasible for a Sponsor to hire as in-house full time staff. Such a CRO has operating procedures and internal guidelines in place that mandate and regulate inter-departmental collaboration. For instance, a medical writer writes the protocol in collaboration with the statistician that offers insights on study design and statistical methodologies, with clinical data management who delve into the details of study conduct as preparation for writing the CRF and construction of the study database and with clinical programing who execute outputs for the data analysis during the study (such as for DMC meetings/ DSURs/ interim analyses) and ultimately for the Clinical Study Report.
An outsourcing model to a single, data-focused CRO is time- and resource- saving, as the Sponsor does not need to hire individual service providers, nor to coordinate their work. In addition, the learning curve is much steeper with such a team. Moreover, a long-term relationship with such a CRO, spanning multiple studies, ensures even shorter learning periods, as the CRO is familiar with the product and the Sponsor’s team.
CDISC standards have become mandatory for all studies as of December 2016. Specifically, SDTM for collected data and ADaM for analysis data. Since there are multiple possible ways of interpreting SDTM, outsourcing of a multi-study project to a single data-focused CRO ensures consistency of SDTM interpretation, making the data CDISC-ready, as well as submission ready and facilitating cross-study analyses. Such a partnership ultimately leads to fully-compliant submissions within the Sponsor-defined timelines.