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JCS Volume 15 Issue 3
 
Patient Selection Bias in Oncology Clinical Trials
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...
24 February 2016 Regulatory | Regulatory V8 I1
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Risk Assessment in Clinical Trials
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, ...
24 February 2016 Regulatory | Regulatory V8 I1
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Coming Together:GrowingIntersectionsbetweenRegulatory and PV
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 co...
12 January 2016 Regulatory
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The Role of Regulatory Agencies in New Drug Development: A Global Perspective
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, a...
12 February 2014 Regulatory | Volume 6 Issue 1
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Risk-based Monitoring: Moving Forward
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 em...
12 February 2014 Regulatory | Volume 6 Issue 1
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Regulation for Paediatric Drug Development in India: Need of the Hour
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 flexibility. Howev...
12 February 2014 Regulatory | Volume 6 Issue 1
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