Clinical Strategy
For your trials to be successful, you need to be well-versed in science and technology. Knowing there is no one-size-fits-all approach to clinical development, we apply an integrated approach to development that leverages our different in-house disciplines. Biomapas' goal is to help you face increasing R&D costs, shorter product lifecycles, and embrace digital transformation in clinical development.
Early Phase
Early Phase Research Unit (BIO1) at Biomapas offers patients and healthy volunteers a comfortable and secure setting. To make things easier for its customers, we assign a project manager to everyone who supervises everything from recruiting to clinical study results. BIO1's capabilities include:
- first-in-human and proof-of-concept;
- single and multiple doses;
- bioequivalence;
- bioavailability;
- drug-drug and drug-food interaction;
- PK/PD;
- tQTc studies.
Phase II
As part of our efforts to assist you to comprehend the complexities of Phase II and III clinical trials, we create unique recruitment strategies for you, engage medical writers, and manage clinical sites to support you. Wherever you are in the world, our clinical project managers keep you informed at every step. While looking for appropriate patients in the EU and Developing Markets, you may benefit from our strong KOL network and patient access.
Rescue Studies
Whatever the situation, Biomapas can help you finish your studies on schedule, improve the quality of your trials, or have your research approved again by a regulatory body.
Your research duration, regulatory filings and ultimate commercialization are all affected by these variables. As a result, after evaluating the extent and kind of study management deficit and identifying the sort of repair needed, we may act as a third-party function.
Authority Interaction
During drug development, marketing authorization, or later in the medication's lifecycle, interactions with health authorities may impact your product's outcome and financial success. Meetings with health authorities allow you to fine-tune your development plan with feedback from potential marketing authorization decision-makers. Biomapas prepares you to get the most out of them and informs you of the authorities' priorities, questions, and expectations.
