If you are considering an investigator-initiated study, we are your CRO.







​The team at Da Vinci Research Solutions will ensure that every aspect of your research venture is valuable and compliant, from concept development to results publication. We have a unique client-centered approach to facilitate the effective start-up and focused execution of your project.

 

Our mission is to provide the FDA-regulated support so that you can focus on your research goals.

 

Your project will be managed by a core group of specialists for liaising directly with pharmaceutical and device companies, regulatory agencies, and clinical sites.  This strategy ensures that a high level of communication, quality, and compliance is maintained throughout the study.  We are dedicated to patients and researchers.  With our expertise and professionalism, you will achieve superior results quickly.


Concept Development:

Study planning and design
Protocol development
Medical writing
Quality assurance of research tools/instruments/procedures
Budget development and negotiations with funding agency

Data Management:
Statistical Design
CRF development
Source document development
​Database design (Part 11 compliant)
Interim and final data analysis

FDA Submissions:
Initial submission
Safety reporting
Interim reports
Annual reports

Project and Clinical Site Management:
Identification and selection of qualified Investigators
GCP training of site staff
Clinical site monitoring and quality assurance
Disbursement of study funds
​Contracting with core laboratories and analysis centers

​We encourage multiple publications and will work to fast-track their development and submission to top-tier journals.

Since investigator-sponsored studies do not typically have internal funding, our model is atypical from industry-focused CROs. Contact us to see how we can move your project forward.

CRO SERVICES FOR SPONSOR-INVESTIGATORS