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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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

Clinical data for two more medicines now available online EMA updates industry guidance on submission of clinical data for publication

The European Medicines Agency (EMA) has published today clinical data for two additional medicines on its clinical data website, which now totals six ...


FDA approves first drug for spinal muscular atrophy


The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle ...


FDA takes action against four tobacco manufacturers for illegal sales of flavored cigarettes labeled as little cigars or cigars

The U.S. Food and Drug Administration issued warning letters to four tobacco manufacturers — Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. — for selling ...


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 ...


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.