Clinical Trial Documents

Our team delivers timely and reliable services in design and development of following clinical trial documents :

* Protocol development and medical writing,
* Design of Case Report Form (C.R.F.),
* Development of ICF as well as its Translation & Back Translation in all Indian languages,
* Preparation of Investigator’s brochure and various logs of routine clinical trial activities.
* Preparation of Expert Report (for EU submission-Module 2.4 & 2.5) and Clinical Study Report

Investigator and Site Identification

Our site feasibility team is expertise in identification of qualified and experienced investigators with well equipped facility, staff and sufficient patient pool at the site. We are consistently maintaining and updating the database of investigators all over India in various therapeutic areas. To request site feasibility any where across the India, do contact us at info@anashclinicalresearch.com

Contract Staffing and Independent Monitoring

Qualified and trained manpower is the key for success of any clinical trial. We provide skilled talent pool of clinical research coordinators and phlebotomists to study investigators and contract research organizations.

Our experienced team has proficiency to monitor and audit the clinical study sites as well as ethics committee operations through out the India with compliance to sponsor’s SOP, protocol and applicable regulatory authority’s guidelines.

Pharmacovigilance Monitoring

Pharmacovigilance is concern with the detection, assessment, understanding and prevention of adverse drug reactions of investigational product, includes both short term and long term side effects. Less common side effects and adverse drug reactions are likely to be unidentified at the time of marketing as only few numbers of patients are exposed to drug during clinical trial. Our efficient Pharmacovigilance team uses valuable tools like data mining and examination of case reports to recognize the relationship between ADRs and drug, before and after marketing.

Liability Insurance Procurement

Insurance is major concern for the ethics committee for the approval of any clinical trial. Further more, insurance provides effective protection to the sponsors against patients’ safety expenses. Here, we provide both investigator as well as sponsor liability insurance for clinical trial.