At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells
On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.
Merge CTMS for Investigators offers groundbreaking ease-of-use, power, and flexibility, helping you organize and centralize your clinical research. Scalable, secure, and backed by the most comprehensive customer support program in the industry, Merge CTMS is the site success solution.
You are constantly facing increased competition for the best studies, mountains of papers and spreadsheets, vast array of complex sponsor contracts to track, and pressure to watch the bottom line.
Merge eClinical OS™, our flagship product, is a truly unified platform designed to help clients manage and run studies faster and more cost effectively.
How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
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