Clinical writing

March 3, 2022

Regulatory Problems about Biomaterials and Medical Devices

In brief All biomaterials and medical devices must comply with various Pharmaceutical Regulatory standards and rules to receive clearance. It covers a range of processes and […]

March 2, 2022

Guidelines for post-market surveillance of medical devices

In brief Manufacturers perform post-market surveillance to gather and assess experience obtained from medical devices that have been placed on the market and determine the need […]

March 1, 2022

What Is the Healthcare Impact of Data Collection?

In brief Regardless of industry, decisions should be founded on facts. The significance of data collecting and analysis based on it The more precise the information […]

February 28, 2022

Evaluating the results of the literature search and screening

In brief Literature searching is generally accepted as an essential part of the literature review process. It entails a study search in the literature to produce […]

February 26, 2021

Literature Screening and Risk Management for Biosimilars – Challenges and Preventive Measures

In-Brief Biosimilars signify a new class of medical products that will significantly impact the clinical practice of pharmacovigilance literature search. They are the same on an […]

February 23, 2021

Uses and Implementation process of Electronic Data Capture (EDC) in Clinical Trials

In-Brief: Clinical Trial Management Systems (CTMS) are an essential part of every clinical trial. Choosing the right CTMS helps address inadequacies on the operational side of […]

February 18, 2021

Challenges faced during FDA Device Approval Process

In-Brief: Effective planning is fundamental to success for any business but an even greater degree in the medical device manufacturing industry. Pepgra covers the top 5 […]

February 17, 2021

How to manage risks in clinical studies? Top 5 tips

In-Brief: Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while […]

February 11, 2021

Significances and Difficulties of E-labelling in the Medical Device Industries

In-Brief: E-labelling is not new evidence; nor is its use partial to the life sciences business. Creating the latest product data available online adds value across […]

February 9, 2021

Top tips for a medical writer to prepare a successful NDA

In-Brief: Medical writers must be subject matter experts of the regulatory control inside and out and know the drug under study in clinical research. To prepare a […]

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 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 […]

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 […]

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 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 […]

February 17, 2021

How to manage risks in clinical studies? Top 5 tips

In-Brief: Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while […]