Capabilities

Our partner provides clinical research services for pharmaceutical and biotechnology product development from Phase I to Phase IV. Phase I trials are typically only done for drugs developed in India. Due to its high and ethical standards, our partner has gained trust and business of seven of the top ten pharma companies and most of the large international Contract Research Organizations worldwide.

CRO services include:

Patient Screening and Recruitment. Project management and study coordinators provide support to the investigators in speedy recruitment of patients. A database of thousands of patients admitted in the hospital and those availing out-patient facilities across therapeutic areas is maintained to aid in recruitment. This ensures that patients from various ethnic backgrounds and demographics are considered for the trial.

Clinical Operations and Project Management. Full time staff of project managers, administrators and study coordinators ensure that planning and execution of the clinical trials is smoothly managed from start to finish. Experienced project management makes every effort to eliminate errors and deliver results in a timely manner.

Quality Assurance. Independent quality control department conducts its own audits on an ongoing basis with a strong focus towards continuous improvement. Observations are tracked and recorded and a remediation plan is rolled out and implemented. At the same time, the focus of QA is on process efficiency and generating relevant management information to evaluate new improvement opportunities.

Therapeutic Expertise. Therapeutic expertise is in over 20 major areas including Oncology, Psychiatry, Gastroenterology, Pediatrics, Cardiology, Orthopedics, Neurology, Medicine, Microbiology etc.

Clinical Trial supply management. Services also include inventory management of clinical supplies. Facilities include ICH compliant storage area and a -70 degrees C refrigerator for serum samples / tissue blocks when required for long term preservation. Our partners are involved in all aspects of overall drug accountability and destruction - from the site initiation to study close out of a clinical trial.

Investigator Training. We effectively address all the training needs of our investigators by organizing ongoing and refresher in ICH GCP, Schedule Y and training required for effectively conducting a trial. Besides, we organize outside training on a regular basis to keep both our staff and investigators abreast of all latest trends especially in technology in order to hone their proficiency.

Ethics Committee. Our independent ethics committee is appointed as per ICH GCP requirements. The Ethics committee is committed to ensuring that due care is being taken at all steps to ensure that there is minimal risk to the patients, the study is being conducted by competent individuals, and that all GCP and ethical guidelines are being followed in spirit and letter.

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