In an increasingly competitive marketplace and ever changing regulatory scenarios, our expertise can make tangible difference in your clinical development program. With our extensive experience across a wide range of therapeutic areas and multiple development phases, we carry following exclusive expertise in the area of clinical development.
Biosimilar and Biologics: Biosimilar and Biologics are different from small molecules and require meticulous micro level planning at all levels. We have to consider many small yet significant issues like cold chain breaks, window period breaks up of dosing schedule, drugs administration and storage at home in case if trial involved drug administration daily etc. Our expertise in this area gives us an edge to proactively plan, predict and manage many operational issues at the beginning itself. This will help us not only to reduce the cost but also manage operations efficiently.
Therapeutic Equivalence Study with Clinical Endpoints: Our strategic approach for successful completion and regulatory acceptance of Bioequivalence Clinical Endpoints Study comes from our experience. We have expertise to understand regulatory challenges, regulatory filing requirements, optimal sample size calculation to prove clinical equivalency, retention of IP and blinding. Our medical writing expert knows how to design study assessment questionnaires and how to train investigators on rating of these assessments. We make the better proposition by integrating the above expert knowledge, for planning and execution of Bioequivalence Clinical Endpoints Study.
Medical Devices: Clinical research is often referred to pharmaceuticals. Although clinical trials for medical devices have many similarities to those of pharmaceuticals however, there are some necessary differences in the way the trials are designed and carried out in case of medical devices. In India, now we have guidance document for clinical evaluation of medical devices and accordingly, we can plan the studies, which will be thoroughly evaluated for the safety and efficacy of medical devices. We have team of experience people in regulatory, medical, and clinical operations for the management of Medical Devices studies. Abiogenesis can help sponsor to register their medical device in India and other Asian Countries.