Pharma companies and Contract Research Organizations (CROs) have a major responsibility to ensure that all business process systems used within the enterprise are implemented, validated and used in a regulatory compliant manner.
Today, as organizations transition to cloud-based technology options, key stakeholders encounter challenges related to compliance, completing multi-regional / multi-site rollouts, defining controls for information security and planning for long-term scalability.
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How to Proactively Prevent Clinical Trial Protocol Deviations and Protocol Violations
Understanding the Importance of a Clinical Trial Protocol The fundamental objective of a clinical trial protocol is to provide common scientific guidance on how to conduct the clinical study in a regulatory-compliant manner and gather data that will ultimately provide answers on the safety and efficacy of the investigational medicinal product. The Guidelines for Good [...]
Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials
What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]
Best Practices for Signal Management in Pharmacovigilance
Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]