We provide global clinico-regulatory services to pharmabiotech and medical device companies for the development of new chemical entities, biologicals and medical devices.
We strategize, develop dossiers and coordinate for pre-IND and scientific advice meetings to firm up the clinical development plans and regulatory strategies.
We are also working on subsequent IND projects for the Life Cycle Management of pharmaceuticals.
Development of efficient clinical development plans acceptable to different Competent Authorities
Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine-tune clinical development plan.
Filing and maintaining IND in the US, clinical trial applications in the EU and India
Global solutions for CLINEXEL clients through worldwide clinical trials
For a global clinical trial, clients are provided options of various countries where AICROS members are present with details about regulatory requirements and clinical trial approval timelines, medical practices, experience of trial sites and local CRO in the therapeutic area and recruitment projections, with costing.
One of the AICROS members will take up the project management and other CROs will provide local regulatory, site selection, monitoring, and study management services and will facilitate in the logistics of import of IP and clinical trial supplies and export of samples to the central lab.
Activities like medical writing, medical and safety monitoring, data management, statistical analysis as well as management of subcontracted vendors like a central lab, will be centralized and managed by one CRO.
Clients will be interacting mainly with the Project Management team (single point of contact)who in turn will coordinate with local CROs, who are AICROS member CROs.
Through AICROS, we can provide global coverage in over 80 countries over 4 continents.
Thus, having global coverage, and extensive cumulative experience, we can offer customized solutions to our clients with strong local service providers.
We deliver added value for companies who intend to conduct multinational studies speedily and flexibly with the highest quality.