Driving ROI: The Case For Investing In Contract & Site Regulatory Document Management Services

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes.  Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs.  In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.

The goal of this study and white paper is to highlight examples of the operational and business benefits that can be realized when outsourcing clinical trial agreements and regulatory document management to a standalone service provider.  The impact of investing in contract and site regulatory document management services is not only strategic but also measurable.  Research conducted by independent research firm the Hobson Group, consisting of five in-depth interviews with DrugDev customers found that DrugDev’s combination of technology and relationships addressed customer challenges and delivered measurable results and a compelling return on investment (ROI).