Services

If you are new to clinical research, let us help you set up your site according to IRB/IEC/IBC and FDA requirements. This can include securing supplies and equipment, building SOPs, required staff trainings, obtaining studies, contract negotiations, source creation, regulatory maintenance and follow up data monitoring.

We can assist with the expansion of studies from Phases I-IV that are available to physicians and sites. This can include getting Physicians pre-vetted with existing CROs, assistance with feasibilities and study start up documents, assistance with budget and contracts, marketing strategies and more.

We provide internal audits concentrated on identifying issues and providing a root cause analysis with corrective and preventive action plans. The internal review can include reconciliation of study documents, support during audits, assistance with follow up responses to FDA 483s, CAPAs, and IBC Inspections.

This ongoing service includes staff and study oversight, data monitoring, deviation tracking, and maintenance of regulatory and compliance standards. Additionally, we can assist with transferring documents and studies into an electronic CTMS system, eSource building and eRegulatory software. 

If you are interested in initiating your own study, we can assist with the protocol and study designs, regulatory submissions, budgeting, source building, recruitment and more. We can even help you obtain grant awards to help fund your study and assist with required follow up reporting.

Do you have a unique need that is not outlined in our typical services? 

Contact us today! We would be happy to hear your individual needs and assess how we can help you with your research goals!