HISTORY teach us the regulatory, geo-political and economic environment for a speedy translation of research into practice. We have built a highly qualified and dedicated team of clinical research professionals with vibrant vision of the clinical trial industry and having an in-depth understanding of the domestic and international ethical and regulatory standards.
"We believe in a world where “culture of research” is developed within the system, which is based on basic fundamentals of integrity, openness and honest work"
Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines Scientific Misconduct is a reality which nobody can shy away from. Furthermore, clinical research is very vulnerable to Scientific Misconduct due to no effective mechanism in place for detecting, investigating and prosecuting Scientific Misconduct in most of the countries.
"Our mission is to deliver distinct service with the highest quality standards which in real helps to develop “culture of research” which is based on basic fundamentals of integrity, openness and honest work."
"GCP MONITOR is an organization established with an ambition of becoming the complete solutions provider organization to the clinical research related to Monitoring, Medical Writing, Auditing and Document Translation."
It is our endeavor to become best service provider for all pharmaceutical and biotech companies for monitoring and data management services. We would like to continue to be prime service provider to pharmaceutical companies"
DCGI inspection includes verification of essential documents to determine whether the trial related activities were in accordance with the protocol, GCP guidelines published by DGHS, Govt. of India and Schedule Y as well as other applicable regulatory requirements. Prior to DCGI audit, We evaluate the CROs with regulatory-audit perspective with the help of checklist to be certain that all technical and quality system are in place.
Our entire team is having strong regulatory audit experience. We help in Site management for and facing various audits of USFDA, EU, WHO and ANVISA. Our team has expertise in audit with regulatory perspective, which helps the CRO to identify the hidden threats. During system audit, we try our best output which ultimately helps CRO during the regulatory inspection.
The RoW (Rest of the World) market is an exciting assortment of more than 35 different markets entailing South East Asia, Asia Pacific, Africa & Middle East. With the distinction between regulated and semi / non-regulated market thinning by the day.
What is the difference between Monitoring and Auditing?
Monitoring-Act of overseeing the progress of a clinical trial.
Auditing - Systematic and independent examination of the trial related activities and documents
Determine the site's ability to conduct the clinical trial.
Verifying qualifications and resources
• Providing Training to Investigator and research team
• Ensure IP handling
• Enrollment and consent procedures
• Verification of Subject's Eligibility
• IP shipment and receipt documents
• Protocol approval documents
• Review progress of a clinical study
• Ensure protocol adherence
• Assure safety of subjects
• Regulatory Compliance (CFR & GCP)
• Close-out Visit
• Assure accuracy of data
A written report to the sponsor after each trialsite visit or trial-related communication
09 SEPTEMBER 2015
The clinical trials on the new drugs are regulated under the provisions of the Drugs & Cosmetic Rules, 1945, amended from time to time.
In order to improve transparency, accountability and efficiency in processing of clinical trial applications and it’s
monitoring, CDSCO with the approval of Ministry of Health and Family Welfare, Government of India has taken initiative
to create an IT enabled system for online submission and processing of application as well as monitoring of clinical
trials in the country.
In the first phase, an IT enabled system for online submission of clinical trial applications has been created and made
accessible to the stakeholderthrough http://octams.gov.in.
On trial basis, the applicants maynow upload their clinical trial applicationsonline through http://octams.gov.in the
purpose of feedback / suggestions only. The usual procedure of submission of application physically through hard copy
shall continue till the system for online submission is made fully operational and adopted by CDSCO.
The suggestions/comments, ifany, may please be forwarded to CDSCO through email atdci@nic.in or phone at 011-23236965
for addressing the issues in consultation with NIC.
CDSCO
03 JULY 2015
The Zonal officer are authorized / delegated to sign test licenses in Form 11 of the Drugs and cosmetics Rules, 1945 for import small quantities of drugs which are approved for more than four years in the contry intended for conducting Bioavailability / Bioequivalence study for the purpose of export in healthy human volunteers.
CDSCO
09 December 2015
Beyond transparency, FDA hopes this initiative will further the discussion about how individuals might respond differently to the same drug. “The amount and quality of the information about how a drug works increase when the population studied has greater inclusion of all types of people in drug trials,”
“How do we know we have enough people to detect a difference in one specific group? What is the right number of clinical trial participants in each sex, race, and age group, and why? Those are some of the questions we need to explore,” Lowy says. “It’s an exciting time to be part of this growing conversation.”
You can sign up to receive email alerts when a new snapshot is published. You can send suggestions and questions about snapshots to snapshots@fda.hhs.gov.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
U.S. Food and Drug Administration
TF-09, Nexus Business Hub,
Nr.Spring Retreat-4,Yes Bank's Lane, Nr.Nilamber Circle,
Bhayali-TP-1, Vadodara, Gujarat, India-390007
Phone Number: 9925023767, 7984885507
Email: info@gcpmonitor.com, gcpmonitor@yahoo.com
