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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows).

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Client-Pharma FAQs During the COVID-19 Crisis

Client Pharma

Response : contain, control or minimize the impacts of any incident(s). Preparedness : take steps before an incident to ensure effective response and recovery. Recovery : take steps to minimize disruption and recovery times. Q: How are Client-Pharma’s warehousing and distribution channels being managed?

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Client-Pharma FAQs During the COVID-19 Crisis

Client Pharma

Response : contain, control or minimize the impacts of any incident(s). Preparedness : take steps before an incident to ensure effective response and recovery. Recovery : take steps to minimize disruption and recovery times. Q: How are Client-Pharma’s warehousing and distribution channels being managed?

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Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

Even still, these approved drug products require a licensed healthcare provider’s prescription. With this in mind, the FDA claims to be committed to sound scientific research into the area and has a number of processes in place for those in the medical research community who intend to study cannabis 1.

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BetterLife’s Recent Acquisition: Taking LSD from Experimental to a Major Therapeutic Application

The Pharma Data

Authors of “ An ethical exploration of barriers to research on controlled drugs ” in the American Journal of Bioethics have been quoted stating, “the classification of drugs as Schedule I amounts to an unsurmountable barrier to research.” For further information please visit www.abetterlifephama.com.

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Transforming Your Informed Consent Process

Cloudbyz

If you’ve been around the clinical research industry, the concept of obtaining electronic consent is probably familiar to you. A secure solution also provides various methods of document authentication by requiring participants to upload multiple forms of identification such as a state ID, driver’s license, and/or a health card.

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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.