Clinical trial begins with an idea. It is then germinated through writing! Synopsis, Protocol, Informed Consent Documents, Case Record Form and all such documents are drafted in-house of QCS. Sponsor has to just share product details and scope of work. We have team of professional medical and content writers to take care of all these writings.
All writing for preparing site master file, and documents for submitting towards Ethics Committee are also written by QCS. If you have data ready with you, our biostatistician can analyze it and medical writers will help you come up with manuscripts and white papers. Our biostatisticians also give inputs in: protocol design, Sample size calculation, Planning and implementing randomization, Analysis methods, Data displays and Interpretations
If you have your list of sites and physicians, good, if not, it’s still okay. Depending on the need of the study, we will identify physicians, talk to them, train them the protocol and GCP and make them ready to undertake your trial! Over years we have good rapport with many investigators and trial sites. Our study site selection process is efficient and quick.
Site screening, feasibility, training and initiation are the steps QCS follow before enrolling subjects in the trial. QCS keeps doing continuous evaluation of sites. This is important, as,domain of clinical research is dynamic and quality is a continuous process! QCS is always open to work with new sites. We believe in exploring and expanding horizons. During the trial, QCS assists in the ICF process, screening and enrollment. It coordinates subject follow-up visits minimizing lost to follow-up and missed visits, manages drug accountability, dis-tribution and logistics. If there is a Central Lab, logistics and sample flow is managed by QCS. It coordinates Monitoring and Audit visits, looks after Subject reimbursements and other issues. In all the manners, Site Master File is maintained and is kept updated. SAE reporting is done on time. Applicable CT insurance is communicated with. After completion of trial, site close out visit is done, data queries are resolved and data is locked. Archival is done at site/per agreed. EC and Regulatory office are informed and Study Report is sent to the client.
Clean, high-quality data is one of the most critical elements of any clinical trial. To accomplish the same, site management an important aspect. Site management system of QCS assures the investigators peace of mind, and they can focus on clinical aspect, enrolment and follow-ups of patients.
Per need, QCS deploys clinical research coordinators (CRC) at the site to perform day to day activi-ties. The CRCs are GCP trained individuals and they perform according to the protocol. The CRCs and CRAs (Associates) coordinate with the investigators, local EC and QCS to deliver on time.
QCS will help you submit the dossier to the DCGI. Specifically, QCS can assist you with the following activities:
QCS believes in continuous training and education, both internally, with our own team and exter-nally with our clients.
It not only is a regulatory requirement, but it also makes sure that everyone is on the same platform. All QCS team members assigned to a project are trained and well versed in ICH-GCP and regulato-ry guidelines.
India has a large and diverse patient pool in almost every therapeutic area. India has an added ad-vantage in clinical research. Quest Clinical Services has expertise and provides full-service clinical development solutions in almost all of the therapeutic areas.
Our network of investigators belongs to a whole spectrum of therapeutic areas which have the capability of investigating wide range of health supplements, drugs and medical devices. In recent years, herbal and nutraceutical products have become increasingly popular.
We offer our services in designing and conducting trials for these products as well.