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Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Covid-19 vaccines approved for use in India – What you need to know Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin.

Clinical Trials Articles

Clinical Trials |
Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India

Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India Summary As clinical trials are increasing in demand and complexity, more time, capital and efforts go into its management and successful completion. Indian contract research organizations (CRO) have seen a remarkable rise in demand due to low-cost structure, updated regulatory standards, and timely

Clinical Trials |
The Role of Clinical Research Services in India in Meeting Regulatory Expectations

The Role of Clinical Research Services in India in Meeting Regulatory Expectations Introduction In the field of clinical research, where novel findings and transformative medical breakthroughs emerge, regulatory compliance is a crucial cornerstone. In regulatory expectations meeting clinical research provides global Clinical trial approval, safety reporting, test license services, etc. Clinical research organizations in India

Clinical Trials |
Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies

Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies Introduction Clinical research organisations in India have become leaders in guaranteeing adherence to complex regulatory frameworks. By means of their steadfast dedication to maintaining ethical standards and meticulous attention to detail, these organisations are essential in negotiating the intricate regulatory environment and

Drug Articles

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The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug

Phase 1 Trial
Phase 2 Trial
Phase 3 Trial
Phase 4 Trial (PMS)
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Medical Devices Articles

Medical Devices |
Best Practices for Designing Medical Device Clinical Investigations

Best Practices for Designing Medical Device Clinical Investigations What is a clinical investigation of medical devices? Devices, much like pharmaceuticals, must go through extensive testing processes before gaining approval for use on patients. However, Medical Device Clinical Investigations tend to be more manageable and involve fewer stages compared to pharmaceutical trials. Clinical investigation concerning medical

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug

Biologicals |
Consumer Claims |
Diagnostic Kits |
Drug |
Medical Devices |
Effective Site Management in Clinical Research – Points to Consider · Cliniexperts

Effective Site Management in Clinical Research – Points to Consider Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites. Site management in clinical research Efficient site management is essential to ensure that the clinical

Biologicals Articles

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug

Biologicals |
Drug |
Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Covid-19 vaccines approved for use in India – What you need to know Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin.

Diagnostic Kits Articles

Diagnostic Kits |
Ensuring Success in Clinical Performance Evaluation for IVDs: Strategies for Sponsors

Ensuring Success in Clinical Performance Evaluation for IVDs: Strategies for Sponsors Summary In healthcare, in vitro diagnostics (IVDs) play a vital role in diagnosing diseases and monitoring treatment effectiveness. However, before these crucial diagnostics can reach patients and healthcare providers, they must undergo clinical performance evaluation to ensure their safety and efficacy. The regulatory process

Diagnostic Kits |
Understanding the Importance of Clinical Performance Evaluation for IVDS: Meeting Regulatory Expectations

Understanding the Importance of Clinical Performance Evaluation for IVDS: Meeting Regulatory Expectations Summary In vitro diagnostics (IVD) are tests that are carried out outside the human body to diagnose a wide range of illnesses and monitor various medical conditions. Importance of Clinical Performance Evaluation (CPE) for IVDS is essential for ensuring the accuracy and reliability

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug


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