Services

We audit your site's processes, documentation and data across drug, biologic and medical device studies, then deliver a detailed report with actionable findings that prepare you for FDA, sponsor or IRB audits. Between audits we help you build CAPA plans that hold up, and we prepare the regulatory reports your IRB, sponsors or the FDA ask for.

Our mock inspections also give your staff real practice. They answer an inspector's questions, pull documents on request and walk through their own processes, so when a sponsor auditor or FDA investigator arrives, your team has done it before and stays confident.

We manage and maintain your regulatory documents as protocols and standards change. We can place a regulatory specialist at your site, or maintain your eRegulatory binders remotely and keep everything up to date, which frees your coordinators to focus on screening and enrollment. We also handle sponsor and CRO affairs, including coordinating meetings and overseeing monitoring visits.

Just starting up, or not ready for a full-time regulatory person? Our as-needed regulatory support covers what you need, when you need it.

We review the protocol and schedule of assessments, build a budget that covers the real cost of every visit and procedure, and negotiate counter-offers until the numbers work for your site. Using real-world and industry insight, we track what the market pays and make sure your budgets and contracts keep up with it. We know how much work goes into every visit, and we negotiate to get your site the most for it.

Once a study is running, we can track invoicing and payments so the money you earn gets collected.

Whether you're moving to eSource for the first time or already running on it, we take on as much as you need. For a new implementation we handle system setup and configuration, complete protocol source creation and site training. For sites already on eSource, we take over the source builds, visit schedules and amendment updates that eat into coordinators' time. Every build follows ALCOA+ principles and 21 CFR Part 11.

Already have an SOP package? We run a gap analysis against current regulations, including ICH E6(R3), then review and update your SOPs so they match how your site actually works. Starting from scratch? We write a complete SOP package for you.

Training is built around your site and your team: GCP and ALCOA+ principles, QA/QC practices, inspection readiness, protocol-specific training, or any topic your staff needs to strengthen. When studies get busy, we can also add staffing and data entry support.

We support your site through the entire start-up process and give you the resources to start winning studies. We advise on regulatory compliance and operational management, and we help you meet HIPAA, FDA and OSHA requirements across your research operations.