IDE Clinical Trial Services for Medical Devices

Study Startup

From Pre-Submission to First Patient In

Most of the risk in a device trial is concentrated at the front end. Before you enroll anyone, someone has to determine whether the study is significant risk or nonsignificant risk, write a protocol that answers FDA's questions rather than raises new ones, build the informed consent, and get the reviewing IRB to approve. We handle that groundwork as a single, sequenced workstream so the pieces fit together instead of colliding later.

We start with the FDA conversation. A well-run Pre-Submission tells you what FDA expects on endpoints, sample size, and follow-up before you commit to a design, and it gives you a record to reference when you file. From there we prepare the IDE application itself: the investigational plan, the report of prior investigations, the monitoring procedures, the labeling, and the investigator agreements. For a significant risk device, the study cannot begin until FDA approves the IDE and the IRB approves the study, so we manage both clocks in parallel and keep site startup moving while the application is under review.

Where a device is a candidate for an expedited pathway, we can prepare the request. FDA's Safer Technologies Program (STeP) is a voluntary program for devices that meaningfully improve safety for less serious conditions, and entry runs through the Q-Submission program. We support STeP and Breakthrough requests as part of the broader regulatory strategy, not as an afterthought.

U.S. Sponsor of Record

For Manufacturers Based Outside the United States

FDA requires the sponsor of an IDE to be located in the United States. A company headquartered abroad cannot hold the IDE directly from overseas, which means foreign manufacturers face a structural decision before the science even starts: stand up a U.S. subsidiary to act as sponsor, or engage a U.S. partner to serve as sponsor of record.

We serve as that sponsor of record. That is not a title on a cover letter. It means we take on the sponsor responsibilities in 21 CFR Part 812 on your behalf: selecting qualified investigators and monitors, ensuring the investigation is monitored, securing IRB and FDA approvals, submitting the IDE and its supplements, and keeping FDA and the IRBs promptly informed of significant new information. You keep control of the device and the science. We carry the U.S. regulatory obligations and the correspondence with FDA.

This is the work we do most and the reason international device companies come to us. We know where foreign sponsors get tripped up, from device importation under the IDE to translation of source documents to the logistics of paying U.S. investigators from a foreign entity.

Site Management

Selecting, Qualifying, and Running the Sites

The right investigational sites decide whether you hit enrollment and whether the data holds up. We identify and qualify sites and investigators with the patient population and the research experience your protocol actually needs, then we run them consistently from startup through close-out.

For a multi-site pivotal study, that means qualification visits to confirm a site can deliver, initiation visits to train the staff before enrollment opens, interim monitoring throughout the active phase, and close-out visits at the end. We coordinate the IRB submissions, execute the investigator agreements and financial disclosure collection, manage the clinical trial agreements, and track enrollment and site performance so problems surface early enough to fix.

Safety Reporting

Adverse Events and Unanticipated Adverse Device Effects

Safety reporting in an IDE is governed by hard deadlines, and the sponsor owns them. When an unanticipated adverse device effect (UADE) is identified, the sponsor must evaluate it and report the results to FDA, all reviewing IRBs, and all participating investigators within 10 working days of first receiving notice. If a UADE presents an unreasonable risk to subjects, the sponsor must terminate the parts of the investigation presenting that risk.

We build the safety reporting procedures into the trial from the start, train the sites on what to report and when, run the sponsor evaluation when an event comes in, and make the FDA and IRB notifications on time. We also manage the annual progress reporting, IDE supplements, and the final report so the administrative record stays clean for the eventual marketing submission.

Physician Payment Compliance

Open Payments, Fair Market Value, and Paying Investigators

Paying physicians to conduct research is normal and permitted, but it is reportable. Under the Physician Payments Sunshine Act, device manufacturers report research payments and other transfers of value to physicians and teaching hospitals to CMS, which publishes them in the Open Payments database. Getting this wrong is a compliance problem, not a rounding error.

We help structure investigator budgets at defensible fair market value, keep the documentation that supports each payment, and organize the data your organization needs for Open Payments reporting. For foreign sponsors, we also coordinate the U.S. tax side. Payments from U.S. sources to foreign persons are generally subject to 30% withholding unless a valid W-8 and an applicable tax treaty reduce it, so we make sure the paperwork exists before money moves rather than after.

Documentation

Trial Master File and Study Records

FDA can inspect the sponsor's records, and an incomplete trial master file is one of the fastest ways to turn a good study into a bad inspection. We stand up and maintain the trial master file so it is complete and inspection-ready throughout the study, not reconstructed at the end. That includes the essential documents required under Good Clinical Practice and the sponsor records required under Part 812: correspondence, device shipment and disposition records, signed investigator agreements and financial disclosures, monitoring reports, and the reports required under 21 CFR 812.150. When a study transfers to us mid-stream, we take it over with a documented handover that preserves the record.