Contract Research Project Management
To provide you with the highest level of service, we have core project managers in Washington, D.C., Philadelphia, PA, Boston, MA and Denver, CO. These managers maintain diligent, weekly contact with our network of CRAs to ensure your study is being properly maintained. We will develop a timeline that works for you and keep the project on track. You will receive continuous communication from our project managers, as directed by you.
We can manage both central and local Institutional Review Boarda (IRB) – Ethics Committee Submissions and conduct all follow up, including interim reports, serious adverse event filings and final reports. With experience managing both central and local IRBs, we will handle your regulatory document collection as well as manage both the master file and the clinical site files. We can assist you with your initial regulatory filing depending on your product, as we have agreements with a number of highly reputable regulatory consulting firms.
Safety
Managing your Serious Adverse Events is a service we provide many clients. We have 24-hour Physician coverage available in various specialties. The Medwatches are completed MD/Ph.D’s and submitted either to you, the sponsor or directly to the FDA. We have all levels of medical writing available and agreements with biostatistic groups.
If you need help writing your investigator brochure, we can turn around a well written document quickly.
Data Management
We can take care of all of your data management needs with the help of approved data management vendors. We will be your primary contact.
Quality Control
Whatever your quality needs, our network includes an auditing firm who is able to assist you in vendor audits including GLP, GMP and GCP audits. We are also able to complete database audits. If your firm needs assistance in Standard Operating Procedures we will review your needs and add or amend SOPs as necessary.