At ARIRDMSCRO clinical operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials within the drug/ medical device discovery Project Management department. Our complete team play’s their part in setting up and gathering the vital data relating to how volunteers and patients respond to the investigational new drug. Clinical operations roles, tend to focus on the smooth running of the clinical trial in accordance with trial protocol, ICH-GCP guidelines, regulatory guidelines from compitant authority of a country/region, ICMR guidelines, NDCT guidelines and Indian GCP. The people tasked, with these roles are measured based on whether the trial is on schedule, meets quality, is regulatory compliant and has patient recruitment numbers are at required levels. Operational jobs require individuals to be able to converse and liaise with key opinion leaders at Investigator sites in the drug/ medical devices development process and thus require incumbents to have strong integrity, communication and influencing skills.

Clinical operations are a highly important part of the drug/device development process and encompasses the whole clinical trial process from phase’s I-IV. This part of the process requires expertise, accuracy and speed, as it is essential for a drug/device to get to market as soon as possible in order for the pharmaceutical/Biotech company to receive a return on their initial investment