Featured Content

New evidence extends validation for quality review

Monday, October 2, 2017

The Good ReseArch for Comparative Effectiveness (GRACE) checklist is a simple 11-item tool that considers the study purpose and provides questions to guide high-level evaluation of methods, data quality and analytics for use in health technology assessments of effectiveness and safety studies. It provides a scoring tool to help evaluate studies in the context of the study goal, and can be used by sophisticated and less experienced users.

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Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

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Cybersecurity: Lessons learned in a hacker’s era

Monday, October 2, 2017

Cybersecurity is back in the public eye, with multiple incidents of malware attacks across the globe. Merck recently suffered an attack that disrupted the company’s manufacturing capabilities. Citing concerns about the drug supply, the U.S. House Committee on Energy and Commerce has asked Merck for an update by this week. The potential for cybersecurity intrusions also touches the medical device industry. Most recently, the U.S. Department of Homeland Security and ICS-CERT issued an advisory identifying eight cyber security vulnerabilities in an infusion pump from Smiths Medical. Previously, the FDA issued safety communications regarding vulnerabilities found in certain St. Jude Medical/Abbott cardiac pacemakers and Hospira infusion pumps.

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Regulatory Update, October 2017

Sunday, October 1, 2017

FDA Final Guidance on Waiver or Alteration of Informed Consent

In the July 25, 2017, Federal Register, the FDA announced the availability of a final guidance for sponsors, investigators, and institutional review boards (IRBs) titled, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations In­volving No More Than Minimal Risk to Human Subjects.” It informs sponsors, in­vestigators, IRBs and other interested par­ties that the FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance explains that the FDA does not intend to object to a sponsor initiating, or an inves­tigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.

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FDA Fast Track designations reach 20th year

Sunday, October 1, 2017

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.

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Tracking adoption of risk assessment and RBM

Sunday, October 1, 2017

For all the talk about how risk-based monitoring (RBM) can improve efficiencies in clinical trial processes, the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodology and some organizations have not yet pursued alternatives to traditional monitoring strategies.

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Recipharm and Clinical Trial Consultants partner to streamline clinical trials

Monday, September 25, 2017

Recipharm, a contract development and manufacturing organization (CDMO), recently announced its new partnership with Swedish CRO Clinical Trial Consultants (CTC) for the development of a comprehensive list of services for first-in-human clinical trials. The partnership’s project, titled Recipharm Pathway to Clinic, is geared toward streamlining clinical trials and facilitating research from the early phase of formulation development to trial implementation.

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