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TMI understands that Proof of Concept (PoC) studies are potentially the most critical part of the clinical research process and the importance of conducting early stage studies in a time and cost efficient manner.
Since inception, TMI has been a valuable partner to many clients in addressing the challenges of achieving Proof of Concept. These clients have learned that that India offers the best opportunity in the world to manage this phase effectively and that our unique TMI approach is ideally suited to utilizing India for PoC studies.
TMI staff has substantial, first hand experience in creating value through sophisticated design of PoC studies and are experts in conducting clinical research in India. Our staff works with our clients on a consultative basis to understand their “ideal” research design (ex. Protocol design, stratifying patient populations to measurable clinical metrics) and to then collaborates on trial design in a way that leverages unique factors offered in India to get closest to it. As a result, TMI routinely enables clients to refine their India-based clinical programs to maximize the probability of success in a quality stringent manner that meets the highest global standards.
India Advantages for PoC Studies
Ideal Proof of Concept (PoC) studies result in clear, efficient, and cost effective clinical development strategies. They enable the sponsor to learn whether they have a potential drug, understand treatment effect, identify sub-populations of responders and non-responders, and power future studies correctly. The rising cost of clinical trials, however, makes it increasingly difficult to develop the clinical evidence to justify the investment in “ideal” trial and often lead to the tragedy of having a product that works but fails to show it a clinical trial.
In India, TMI has often conducted early stage studies in an in-patient setting, which due to cost and insurance control, would have had to be conducted in an out-patient setting in the West. The mere process of admitting a patient for a week educating and training the patient enables tighter control, resulting in the highest quality of patient well-being and helps in eliminating “noise” which can confound an accurate trial result. Due to low healthcare reimbursement levels in India, procedures such as MRI or a CTscans cost a tenth of the conventional US/EU. Consequently, it is often possible to include a much broader array of more refined metrics than would be feasible in the US/EU based on cost.
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