pepgra

December 18, 2020

Guidelines on Virtuous Pharmacovigilance Practices

In-Brief: Does the need for protection of patients and public health increasing? Unquestionably yes. The science of regulating and understanding this process is known as pharmacovigilance […]

July 25, 2020

ESTIMATION OF SAMPLE SIZE AND POWER ANALYSIS FOR CLINICAL RESEARCH STUDIES

In brief Clinical research studies the effect of an intervention on a specific population or the causation-association between a predicting variable and a health condition. The […]

July 17, 2020

ROLE OF BIOSTATISTICIAN AND BIOSTATISTICAL PROGRAMMING IN EPIDEMIOLOGICAL STUDIES

In brief Health data contains important information that can help save lives and cro biostatistics services provide information to support public health initiatives. Biostatisticians […]

July 6, 2020

Clinical trial protocol writing: Challenges and Guidelines

In brief: The clinical study protocol is defined as the procedures by which clinical research is conducted A clinical study protocol should provide a clear […]

June 30, 2020

Challenges and Opportunities in Software Driven Medical Sciences

SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run […]

June 24, 2020

Post-authorization stage of product cycle.

What is Product cycle? In pharmaceutical industry, product cycle consists of all processes from drug discovery to launch to access, which is closely monitored by […]

June 20, 2020

Challenges in the study design, conduct and analysis of randomized clinical trials

In brief: The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings. Randomized clinical trials […]

May 12, 2020

Risk managements documents required for the market placement of a medical device compared with a medicinal product

In Brief The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product. Risk management documents/plan […]

May 12, 2020

Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.

Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European Medicines Agency along with interested parties created the Notice […]

April 25, 2020

Clinical Trial Design and Artificial Intelligence

Clinical trials take up the last half of the 10 – 15 year, 1.5 – 2.0 billion USD, cycle of development just for introducing […]

December 18, 2020

Guidelines on Virtuous Pharmacovigilance Practices

In-Brief: Does the need for protection of patients and public health increasing? Unquestionably yes. The science of regulating and understanding this process is known as pharmacovigilance […]

July 25, 2020

ESTIMATION OF SAMPLE SIZE AND POWER ANALYSIS FOR CLINICAL RESEARCH STUDIES

In brief Clinical research studies the effect of an intervention on a specific population or the causation-association between a predicting variable and a health condition. The […]

July 17, 2020

ROLE OF BIOSTATISTICIAN AND BIOSTATISTICAL PROGRAMMING IN EPIDEMIOLOGICAL STUDIES

In brief Health data contains important information that can help save lives and cro biostatistics services provide information to support public health initiatives. Biostatisticians […]

July 6, 2020

Clinical trial protocol writing: Challenges and Guidelines

In brief: The clinical study protocol is defined as the procedures by which clinical research is conducted A clinical study protocol should provide a clear […]

June 30, 2020

Challenges and Opportunities in Software Driven Medical Sciences

SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run […]

June 24, 2020

Post-authorization stage of product cycle.

What is Product cycle? In pharmaceutical industry, product cycle consists of all processes from drug discovery to launch to access, which is closely monitored by […]

June 20, 2020

Challenges in the study design, conduct and analysis of randomized clinical trials

In brief: The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings. Randomized clinical trials […]

May 12, 2020

Risk managements documents required for the market placement of a medical device compared with a medicinal product

In Brief The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product. Risk management documents/plan […]

May 12, 2020

Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.

Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European Medicines Agency along with interested parties created the Notice […]

April 25, 2020