Clinical Trial Compliance for Clinical Trials In India

 

As the clinical testing of new drugs on human beings can be life threatening, the drugs and their clinical trials must get a green signal from the regulatory authorities before testing. The government approves drugs and clinical trials only if the trials satisfy and are in compliance with the guidelines of the regulatory authorities. Clinical Trials India provides clinical trial compliance services that include:

 

• Clinical Trial Application (CTA)- Clinical Trials India apply to regulatory authorities on behalf of the clients for Clinical Trial Approval. The task of dossier submission is made easy by the expert regulatory professionals.
• Mock surveys and Auditing for Clinical Trials Compliance in India- Auditing involves the pre -informed or uninformed inspection to check whether the clinical trials are proceeding in compliance to GCP (Good Clinical Practices), GLP (Good Manufacturing Practices) , and GLP (Good Regulatoy Practices) or not.
• 21 CFR compliant Electronic Documentation - 21 CFR part 11 precisely deals with electronic capture of Case Report Forms. 21 CFR is a code of Federal Regulations. It is a text enacted by the FDA whose purpose is to specify the way in which documents, electronic data and digital signatures must be managed for clinical trials compliance.

 

• Clinical Trial Site Management- Our site management services are delivered through highly experienced team for clinical trials in India. Our services promise,
• Clean data generation at the site, inspected by qualified and experienced personnels.
• Clinical Trial Protocol compliance at the site that confirms ICH GCP compliance and compliance with other regulatory guidelines.
• Generation of error free data.

 

• Clinical Trial Project Management- Our dedicated project management team strives to deliver projects backed by quality assurance and on time deliverables. Our managers build a top-notch project team that works with a focus to tailor the project to fit the needs of our clients. The services offered by our project management team includes:
• Site identification keeping in mind the ICH GCP trained staff availability and hospital infrastructure.
• Budget negotiation.
• Site visit to confirm the attendance of all the team members, assuring the team members have received and read the study material, ensuring that the team members are trained on reporting AE/SAEs and regulations, and to ensure that the equipments for study have been carefully calibrated and installed.
• Assisting the Investigators at the Informed Consent Process.
• IVRS for patient's randomization.
• Ethics committee submission and approval on behalf of clients.
• Our Monitoring services ensure error free data and error free Electronic Capture of the data and clinical trial in compliance with the regulations.

 

Following all the clinical trial compliance according to the laws and guidelines we provide two major Clinical Trial Compliance services for accomplishment of successful clinical trials in India-

Clinical Trials Compliance Consultancy

 

Clinical Research Regulatory Documentation Compliance