Brochure | August 29, 2012

Contract & Regulatory Services Brochure

Source: DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones—including drug shipment, IRB approval, and patient randomization—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—from protracted contract negotiations to redundancy and lack of quality control in regulatory and financial disclosure documentation. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs.

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