Our SMO platform provides contract research organizations (CROs), pharmaceutical and biotechnology companies, medical device companies, and especially clinical investigation sites – our critical partners – with excellent clinical-trial-related services, including:
*In Europe, these specific items are often performed by the Sponsor or CRO, rather than the SMO.
We supply extensive support for pre- and post-marketing trial activities – powered by experienced partner-providers for pharmacovigilance and clinical data management – ensuring that your trials deliver and comply with current regulatory standards.
We support your PV with end-to-end project management, including:
Our pool of experienced clinical trial professionals ensure that the trial is conducted according to the clinical investigational plan and applicable requirements.
Our specialization in clinical research regulation allows us to offer consulting assistance in conducting relevant regulatory submissions, as well as to liaise on behalf of our business partners with the relevant competent health regulatory authorities.
Our services and project management leads can consult and work with biostatistical, PV, project management, and CDM teams, to generate accurate, time-efficient, cost- effective documents that comply with the highest bioethical and scientific standards.
Serving as the medical expert for assigned clinical trials, this service provides input on the design and conduct of clinical trials, assessment and interpretation of clinical data, and will contribute to investigator training, including good medical and clinical practices.