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10. Pyoderma Gangrenosum...
Regulatory

Patient Selection Bias in Oncology Clinical Trials

Randomised clinical trials are the gold standard for evaluating new treatments and moreover, they have become part of everyday practice. Many international guidelines recommend RCT …

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clinical trial
Regulatory

Risk Assessment in Clinical Trials

Risks are an integral part of clinical trials. We routinely come across various risks while managing clinical trials, which are related to quality, safety, timeline, …

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09. Clinical Research ...
Regulatory

Coming Together:GrowingIntersectionsbetweenRegulatory and PV

Regulatory authorities’ emphasis on the centralisation and standardisation of all product-related data has a profound effect on life sciences and pharmaceutical companies, compelling them to …

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Regulatory

The Role of Regulatory Agencies in New Drug Development: A Global Perspective

Regulatory agencies worldwide play a critical role in healthcare as independent reviewers and approvers of applications made by sponsors to conduct clinical trials, and ultimately …

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Regulatory

Risk-based Monitoring: Moving Forward

After issuance of the final guidance document by FDA on Oversight of Clinical Investigations – A Risk-based Approach to Monitoring, the clinical trials industry is …

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Regulatory

Regulation for Paediatric Drug Development in India: Need of the Hour

India is a popular location for clinical research due to the multitude of benefits it offers, including a large patient pool, low costs and ethical …

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