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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

Immunic, Inc. Added to NASDAQ Biotechnology Index

NEW YORK, Dec. 14, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020.
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White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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