Clinical Trials Compliance

 

Our mission at Clinical Trials India is to satisfy our clients with the range of our services under expert hands and management. We are acutely cognizant of capital value and intellectual efforts of our clients. Clinical Trials India is vested to provide highly professional and experienced staff to work for our clientèle.

We work to preserve the cost to conduct the clinical trials to bottom line in parallel with all Clinical Trials Compliances required which is the reason for our long lasting relations with clients.

Our consultants are highly experienced regulatory affairs professionals who have around two decade expertise in the concerned field. The consulting services supports clinical research organizations across India and across the borders in regulatory concepts. Our clinical trials compliance consulting services include:

 

• Advising the clients on clinical trials compliances in regulatory issues.
• Consulting and following up regulatory agencies.
• Query solving by consulting the clients as well as regulatory agencies.
• Support the clients on strategy for submission.
• Registration of drugs.
• Technical development.
• Pre clinical and clinical testing of biotech products.
• Requirements for dossier submissions.
• Timely close and delivery of the project.
• GCP compliance training.
• Pre clinical trial monitoring
• Clinical trial monitoring
• Interim clinical monitoring to ensure quality.
• Monitoring upon closing of the clinical trial.
• Clinical research management includes contract negotiation on payment issues.

 

Apart from the hard core consulting services to clinical research organizations in India, we also provide trainings on regulatory aspects and clinical research aspects. The training is provided in the form of on line training. This online training is provided in the form of modules divided into three levels. The levels include beginners level, medium level and advanced level. The modules are beneficial to a range of audience from students to RA professionals.

 

We also provide IVRS services. IVRS is Interactive Voice Response Services. This technology is meant for patient randomization at the trial sites. This is a very convenient way of registering patients for clinical research.

 

Integrated to our IVRS services, are our web services. These provide online forms for registration and other tasks. All the technologies offered by for clinical research by Clinical Trials India are in compliance with 21 CFR part 11.

 

Our Services to Clinical Research Organizations available on request on following Clinical Trial Compliances include:

 

• Auditing.
• Medical writing.
• Protocol Development.
• Case Report Form design.