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Tunir Das
The Accelerated Approval Program of the FDA provides for conditional approval of drugs that show an effect sufficiently desirable, compared to available medications, based on surrogate endpoints considered reasonably likely to predict clinical benefit. This path acknowledges the urgency that some medical conditions carry and tries to provide earlier access to potentially life-saving therapies for patients.
Key Guidelines for Accelerated Approval
eClinical Companies and Their Role in Accelerated Approvals
eClinical companies, like Cloudbyz, also play a significant role in the facilitation of the acceleration of drug development:
In conclusion, the role of the Accelerated Approval Program is to make groundbreaking innovative therapies available as quickly as possible to people with seriously unmet medical needs. eClinical companies play a huge part in this, providing necessary tools and technologies that optimize clinical operations, improve data integrity, and make regulatory compliance easier for companies. With these efforts being collaborative, the stakeholders can use the accelerated approval pathway options more effectively, thus benefiting patients waiting for new treatments. For a pharmaceutical company, working with a proven, trusted eClinical provider can mean the difference between attaining the desired results and getting important, powerful new therapies into the marketplace quickly as it moves through the Accelerated Approval Program.
Cloudbyz eClinical is one of the fastest growing cloud based eClinical systems natively built on the Salesforce platform. Our solutions help customers of all sizes conduct clinical trials efficiently to bring life saving therapies faster to market and improve patient lives. Our eClinical platform comprises CTMS, EDC, eTMF, Safety & Pharmacovigilance and Patient Recruitment solutions.
To know more about the Cloudbyz Unified eClinical Platform contact info@cloudbyz.com
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