SERVICES

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.

Monitoring/ Audit

Prime quality and deliverable based Clinical Monitoring services

Medical Writing

Medical writing services for Study Protocols, ICF, Study Reports

GCP Training

Good Clinical Practice = Ethics + Quality Data.

Document Translation

Translation of clinical research documents

Compliance with GCP standards provide public assurance that the rights, safety and well-being of trial subjects are protected, and that the clinical trial data are credible.

ABOUT US

"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.

Free Informed Consent Process

60% Complete

Mission and Vission

60% Complete

Our Mission:

"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."

Our Vission:

"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."

OUR ACTIVITIES

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"

Domestic Services

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.

Regulated Contries

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) Contries

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.

FAQ

60% Complete

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

OUR WORK PROCESS

Pre-study Qualification Visit

Determine the site's ability to conduct the clinical trial.
Verifying qualifications and resources

Before Study
Visit

• Providing Training to Investigator and research team
• Ensure IP handling
• Enrollment and consent procedures

First Enrollment/ Dosing Visit

• Verification of Subject's Eligibility
• IP shipment and receipt documents
• Protocol approval documents

Routine Monitoring Visit

• Review progress of a clinical study
• Ensure protocol adherence
• Assure safety of subjects
• Regulatory Compliance (CFR & GCP)

Close-out Visit


• Close-out Visit
• Assure accuracy of data

Monitoring Report


A written report to the sponsor after each trialsite visit or trial-related communication

NEWS

09 SEPTEMBER 2015

IT ENABLED SYSTEM FOR ONLINE SUBMISSION OF APPLICATIONS OF CLINICAL TRIAL-REG

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

Office Order for Old Drugs TL BA/BE (export)

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

Designing Better Clinical Studies

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

CONTACT GCP MONITOR

Mapswebsite.net

Contact Info

S17-E, Indiabulls Megamall,
Under Jetalpur Overbridge,
Nr. Dinesh Mills, Akota,
Vadodara,
Gujarat, India
Pin-390020
Phone Number: 9925023767, 7984885507
Email: info@gcpmonitor.com
Email: gcpmonitor@yahoo.com

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