All projects are efficiently handled by qualified persons who are well experienced in different therapeutic domain like Oncology, Endocrinology, Cardiovascular, Dermatology, Infectious Disease, Orthopedic, Respiratory and Metabolic disorders. We always believe in single point of contact with our Clients and the Investigative site so that the work can be result oriented.
Our Clinical operations Team conducts Phase II to Phase IV clinical trials for Pharmaceutical and biotech companies without compromising on Quality, Ethics and Confidentiality.
To ensure that our clients receive quality services in compliance with applicable regulatory guidelines, we provide our Clinical Research Associates (CRA) with an excellent training in Project Management, Site Management, Clinical Trial Monitoring. Clinical Trial Supply Management and Vendor Management.
All the sites will be managed efficiently once the trial starts and will always look out for excellence in managing the site . The protocol will be strictly adhered so that there are no protocol violations and all the subjects enrolled as per the protocol. The subjects integrity and confidentiality will be at most priority and will also help the sites in filing the data properly and also in addressing site related issues. Further, will also communicate on behalf of the site with the Ethics Committee. Site Management also covers the area were the site is required for up gradation as per the trial requirement. In case of new sites the site individuals are trained as per the protocol and also help them to do the trial as per the GCP.
We ensure the conduct and timely execution of Clinical Trial Projects. We have a strong organization who are well trained in ICH GCP,and regulations . The CRAs travels to the site every four to five weeks or as per the requirement of the trial, to ensure that the protocol is been followed strictly and the data collected are all proper and also see that the sites are in compliance with the protocol. Their other work include monitoring the data and resolving any protocol related issues which may arise in the project.
Clinopsys Clinical Research provides end to end management of clinical and other supplies. we also ensure timely deliver of the Investigational product and also help in collecting the sample from the site to deliver it to the central Labs.