Global Compliance

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...

Consulting

Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get real

Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get realcontribution by John Pappan, Director of Regulatory Affairs, Medical Device & Business Strategy

Global Compliance

Data Protection Part 3: Key Considerations for Clinical Trial Recruitment

With the advent of the EU’s General Data Protection Regulation, individuals now have expanded rights to information regarding the use of their personal data. These changes impact several aspects of the clinical trial recruitment process and may require sponsors and CROs to update their data collection and protection protocols and processes for informed consent. Consent...

Global Compliance

Data Protection Part 2: Ensuring Study Start-Up Compliance With GDPR

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy notice...

Clinical Research: Phase 1 - Phase 4

Data Protection Part 1: Understanding How GDPR Affects Clinical Trials

Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, including clinical research. The objective of the GDPR is to strengthen and standardize the protection of personal data across the EU, including ex-EU data that is processed within the...

Global Compliance

Why and How Global Healthcare Product Regulators are Joining Forces

In May 2012, the leaders of 30 medicine regulatory bodies from around the world gathered at the 65th World Health Assembly in Geneva, collectively puzzling over how to improve cooperation among them. Their answer came later that year: form the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of Heads of Agency (HoA)...

Data Management & Biostatistics

ICH GCP Update: Sponsor Control of Clinical Trial Data

Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of...

Global Compliance

Updates to the ICH GCP (Good Clinical Practice) Guidelines: Quick Review

First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...

Global Compliance

7 Sponsor Responsibilities Under Good Clinical Practice Guidelines

Sponsor responsibilities under good clinical practice (GCP) guidelines are extensive. While many of these tasks may be — and often are — transferred to a contract research organization (CRO), the sponsor is ultimately responsible for study quality. But just what do sponsors need to make sure their clinical trial meets GCP standards? Read on to find out....

Consulting

Understanding GCP Basics

Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officials...