iProcess was founded by a team highly experienced in handling outsourcing projects for India. Included in this team are former senior executives from Allergan Pharmaceuticals. Our Scientific Advisor is a Director of Oncology at a premier university research center in the US. Apart from the executive team, we have highly experienced Clinical Project Managers and Monitors with Master’s Degree in Clinical Research and several years working on clinical research based projects.
Outsourcing of clinical functions typically refers to the hiring of an outside entity to conduct some or all of the technical tasks associated with conducting a clinical trial. Outsourcing technical tasks such as writing, statistical analysis, study monitoring, database design, etc. to contract research organizations (CROs) was an increasing trend in the late 1900’s. As part of that trend, U.S. firms have been outsourcing site tasks to India for some time. Drawn by cheaper costs and faster start-up times, they almost always outsource investigative sites.
The complicated nature of clinical research, exacerbated by the numerous parties involved in the process — from the sponsor, to the contract research organizations and site management organizations to which companies often outsource trial management, to investigators and the patients, leads to a lot of problems.
If the sponsor is to minimize challenges involved in managing outsourced clinical trials, it must learn to establish relationships with the right partners, and manage the project and process tightly.
Key to managing the relationship is, knowing which partner to select. A company might choose to work with one provider for all outsource components to ensure transparency across functions, clear accountability, and fewer oversight complications, etc………But if a sponsors would want to only outsource a part to one particular CRO, and the rest to some other’s, then this could be very time consuming.
iProcess Inc initiated a survey for better understanding of the clinical research practices of the industry. The survey had been conducted with questions focused on the management, regulatory, quality and financial aspects of clinical trials and manufacturing. Data had been collected from firms around the world.
One of the goals of the survey was to provide benchmarking quality for outsourcing. The quality of data delivered by a site is a function of the quality of data demanded by it. Because sponsors set the tone for their home countries, a look at their practices can help companies better understand what to expect when conducting clinical trials in India.
iProcess Inc soon emerged as a preferred partner for US and European sponsors to outsource there clinical trials, research etc to India, due to its in-depth knowledge about the markets in India as well as a thorough know-how about the companies they recommend to the sponsors to associate with.