Best Practices for Complying with EMA Policy 70

EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post … Continued

Meet Pharma Transparency Mandates & Engage Study Participants

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and … Continued

Certara’s Synchrogenix Division and PleaseTech Partner to Streamline Document Redaction Services

PRINCETON, NJ – Aug. 4, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its regulatory and medical consultancy, Synchrogenix, is partnering with document co-authoring and collaborative review specialist PleaseTech Ltd. to deliver a seamless regulatory document creation process.

A Streamlined Approach to Policy 70

David Cornwell, Founder and CEO of PleaseTech and Lora Killian, Synchrogenix Director of Transparency and Disclosure, provided an in-depth review of the full streamlined process created as a result of the partnership between Synchrogenix and PleaseTech.

Synchrogenix ClinGenuity Redaction Management Solution (CRMS)

Synchrogenix’s unique AI engine, has created an engine that is built on natural language processing and recognition. Because of the power behind our unique AI, the engine can be configured to identify PPD and CCI the same way an individual would be trained on these definitions. The process of identifying and redacting sensitive information becomes automated and significantly more accurate.

Transparency & Disclosure in Clinical Trials

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.

Engaging the Public in the Clinical Research Process

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trial put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trials … Continued

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