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Bridging Study

A bridging study is defined as a supplemental study performed in the new region to provide Pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the new region. Such studies could include additional pharmacokinetic information.

Welcome to GCP HelpDesk Website 

In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations.  This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Research with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk   and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback  page and we appreciate your suggestion and comments.

Clinical Research Today

Pharmacists’ role in flu prevention

According to recent World Health Organization (WHO) data, in South America flu and other respiratory viruses declined in most countries. Overall, taking the flu shot is the best way to avoid the flu. When fewer ...


WHO issues new guidance on HIV self-testing ahead of World AIDS Day


GENEVA -29 NOVEMBER 2016, In advance of World AIDS Day, WHO has released new guidelines on HIV self-testing to improve access to and uptake of HIV diagnosis.


FDA research to help speed development of Zika virus vaccines and therapeutics


A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in READ MORE

FDA approves Intrarosa for postmenopausal women experiencing pain during sex


The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. ...


How to make better use of patient registries to collect high-quality data on medicines


The workshop organized by the European Medicines Agency (EMA) on 28 October 2016 also aims to explore how new registries ...


FDA approves new device for prevention of recurrent strokes in certain patients


On 28 Oct 2016 the U.S. Food and Drug Administration approved the Amplatzer PFO Occluder ...


FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Amjevita is approved for the ...


FDA allows marketing of clot retrieval devices to reduce disability in stroke patients

The U.S. Food and Drug Administration, allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other ...


FDA approves Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.


Addressing challenges of innovative cancer immunotherapy medicines


EMA workshop to discuss treatments based on genetically modified T-cells. The European Medicines Agency’s ...


FDA updates draft guidance on premarket safety notifications for dietary supplement industry

The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety ...


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.