Translational clinical trial

Clinical Trial Translations for All Phases of the Development Cycle Precision translation solutions for clinical trials from qualified, in-country subject matter experts. Home 9 Clinical Trial Translation. Clinical trials account for an enormous portion of the investment required to bring drug therapies, medical devices, and treatments to market in any country.

Our Tools and Methodologies. Multilingual Clinical Trials Today, a growing number of clinical trials are conducted globally. We have experience translating:. COVID created a new clinical and translational research landscape, and the efforts highlighted in this journal issue demonstrate how researchers can continue to address COVID and future public health emergencies. Read more about this special issue. Multimedia Photos Videos Infographics. Translational Science Spectrum.

For most of the therapeutics the patent protected periods usually include the research and development time span and more and more drugs are soon falling down the patent cliff.

This scenario makes India a preferred place for global clinical trials keeping in view the demographic advantage. India has a large and heterogeneous population pool of over one billion with many regions considered as conserved gene pools for pharmacogenomic profiling of newer therapeutics. This is compounded by a fast accrual rate in clinical trials creating efficiency much needed by the pharmaceutical industry. India has adopted the international GCP and integrated it with the schedule Y as an essential component under the Drugs and Cosmetic Act Approval is usually provided in 12 weeks from the date of submission.

The ethics committees review research protocols in almost 4 to 6 weeks. In India many institutions also have Scientific Review Committees SRC for reviewing the scientific rationale of the clinical trial for ensuring more safety and the well being of clinical trial patients. Once the clinical study is approved by the Scientific Review Committee the study is then submitted for approval to the ethics committee.

DCGI approval is also mandatory for obtaining a Test License to import clinical trial supplies, which usually takes 2 weeks. Around 14 weeks in total are taken on an average to complete the above processes for initiating a clinical trial in India. After the regulatory approval is granted for a clinical trial in India, the Director General of Foreign Trade DGFT provides approvals for export of blood or other biological samples.

This may take an additional weeks. In the wake of Research integration efforts by the Translational Health Science and Technology Institute of the Department of Biotechnology, Government of India and a healthy clinical trial infrastructure all round the country, India is all poised to bridge the gap between scientific discovery and clinical research as envisioned in the Critical Path Initiative of the FDA.

Frank R, Hargreaves R. Nat Rev Drug Discov. Epub Feb Do not forget a coaxing call to action, but also a way to decline. Put the final call to action.

Skip to content Featured. Abstract The drug development landscape is markedly different today than it was a decade age. This often requires a deeply singular knowledge base. Clinical research is what science, at its core, is all about: the careful and pragmatic testing of mature hypotheses in controlled environments. Translational research seeks out the possible human applications of scientific and clinical findings and translates them into strategies for improving healthcare delivery, patient outcomes, and community health.

This is a horizontal knowledge role that unites different specialties. Whether linking the laboratory to the clinical trial or linking the clinical trial to the population, translational research is about putting theory into practice and developing new theories about how practice can take place in a variety of diverse settings.

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