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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.
Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
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News and Press Releases

Automated testing of pharmaceutical packaging

Test-result reproducibility and traceability are essential when testing pharmaceutical packaging and medical products. Zwick has developed a robotic testing system for automated testing applications ranging from childproof bottles (withpress-and-turn caps) to auto-injectors and insulin pens; tests on these include determination of the release force. As well as increasing specimen throughput and reducing per-specimen costs, automation reduces operator influence, while releasing laboratory staff for more demanding activities in line with their skills and qualifications.
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White Papers

Clinical Trials in Russia Orange Paper: 1st Quarter 2014

Synergy Research Group

In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
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Industry Events

SCOPE Europe: Summit for Clinical Ops Executives

16-17 October 2018, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clin ops execs, functional heads, category managers and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.
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