Blog

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 […]

January 4, 2021

Recent trends in genomic biomarkers

Brief: Cardiovascular disease is a significant health concern worldwide despite having many genomics developments providing valuable new candidates for better biomarkers and novel therapeutic targets. […]

January 7, 2021

Post authorization studies for clinical research purposes

Brief: Have a look at post-authorization safety studies and important pharmacoepidemiological and pharmacovigilance aspects in clinical research in this Pepgra blog. PASS covers different types […]

January 11, 2021

Uses of Patient Registries for Clinical Studies to Acquire Unwavering Data

In-Brief: The patient registry is a specific study or a detailed survey of research question or hypothesis generally. Clinical research statistical service is a collection of […]

January 18, 2021

Practical Guidance for Biomarkers into Early Phase Clinical Research Purposes

In-Brief: Healthcare data analytics solutions provide a powerful approach to understand the spectrum of disease with applications in observational and analytic epidemiology, screening and diagnosis randomized […]

January 18, 2021

How Electronic Health Records transforms the Healthcare Sectors?

Brief: Advancements in the medical field and the proliferation of diagnosis and screening tests have to create mountains of data on patient healthcare. Digital information technology […]

January 22, 2021

How regulatory writing plays an essential role in clinical research?

In-Brief: There are two main parts in medical writing, medical communication and regulatory writing. Pepgra blog focuses on regulatory writing, which involves preparing the clinical study and […]

January 25, 2021

Reporting Side Effects for Any Medical Products, Devices or Drugs

Brief Humans differ in their biological reactions to medical products or drugs but not all adverse reactions associated with the use of medical products can be […]

January 28, 2021

Literature Review of Drug Development using Real-World Evidence

In-Brief: Real-world evidence, which is based on data gathered during routine clinical exercise, has the potential to make a significant impact in nearly every phase of […]

February 1, 2021

How to identify and recruit patients for secured clinical trials? Top 10 tips

In-Brief: The best clinical trial recruitment strategies start by focusing on the patient perspective. From there, it helps to get creative. A reliable clinical trial patient […]

February 4, 2021

What are the EMA Guidelines for Clinical Trial Management?

In Brief Clinical trials are the scientific way of assessing medications’ efficacy in treating a medical condition and side effects. EMA guidelines for clinical trial regulations […]