Clinical operations
Research that runs for years needs a team that stays for years.
We run three kinds of research: prospective data collection and registries, including post-marketing studies; prospective biospecimen acquisition; and research networks for disease foundations. Each starts with study strategy, runs at physical, virtual, or hybrid sites, and keeps participants engaged to the last visit.
Send us a message. Nurse Alicia and her team will get back to you.
Design · Sites · Recruitment · Follow-up
Recruitment begins before the study does.
Most recruitment and engagement problems are design problems in disguise. We solve them first.
- Design.Inclusion and exclusion criteria that mirror the real population, and study activities participants will actually complete.
- Sites.Know where the participants are, then choose the site strategy that reaches them: physical, virtual (with EHG as the virtual site), or hybrid, with real-time site activation support when time matters.
- Recruitment.We’re clinicians who understand the patient journey. That shapes patient-forward outreach that finds the right participants, then consents and enrolls them, remotely when that serves them best.
- Follow-up.The team that designed your study stays with your sites and participants. Low turnover and lasting relationships keep them engaged year after year.
Right criteria. Right sites. Engaged participants. Follow-up that lasts.
Send us a message. Nurse Alicia and her team will get back to you.
Three services · One clinops team
The long part of research is our part.
01 / Data
Prospective data collection and registries, including post-marketing studies.
A registry is only as useful as its year-ten data. Registries, natural history studies, and post-marketing requirements and commitments, with long-term follow-up on the schedule your protocol sets, for as many years as it sets.
02 / Biospecimens
Prospective biospecimen acquisition with chain of custody.
A sample is only usable if its consent and chain of custody hold up. 20+ years of collection studies for diagnostic companies, biobanks, and nonprofits, domestic and international: rare diseases, rapid collection timelines, and the populations hardest to recruit. Chain of custody documented from participant to biorepository.
03 / Networks
Research networks for disease foundations.
Your foundation has the patient community. We provide the clinops team that runs the research. 20+ years building and running them for foundations working to change the course of their disease: sites, registries, recruitment, and the technology behind them. Every disease is different. Every network is built for the community it serves. Your study and your constituents become our mission.
Staff augmentation from people who’ve done the job: investigators, coordinators, CRAs, regulatory, data, and program leadership, short-term or fractional.
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Decentralized · Virtual · Hybrid
Go to the participant.
We’ve run decentralized studies for more than ten years, since before the term went mainstream. When it serves the study, EHG can be both the CRO and the site, so participants take part from home. When EHG is the site, Nurse Alicia serves as investigator, with a physician investigator added when the study requires it.
- Remote consent and re-consent with a clinical operations professional. Our process is built on Nurse Alicia’s philosophy: consent is not a document. It’s a relationship built on trust and mutual respect. No participant is ever alone.
- ePRO, electronic stipends, and remote medical record collection, all on the participant’s schedule.
- Support across time zones.
- Studies managed on current research technology, with AI-supported workflows governed by ClinicAL™ by EHG and reviewed by a qualified clinops professional.
A team that genuinely likes talking with participants.
Send us a message. Nurse Alicia and her team will get back to you.
Continuity · Long-term follow-up
Enrollment rewards speed. Follow-up rewards continuity.
Gene therapy · Long-term follow-up
Fifteen years. One team the whole way.
What long-term follow-up looks like when the team that starts the study stays with it.
- Years 1–5: Annual exams
- Years 6–15: Annual contact by phone, visit, or questionnaire
- Year 0Enrollment and treatment. Baseline data and specimens collected.
- Year 5Annual exams give way to annual contact. Same team, current contact details.
- Year 10Sites close, staff turn over. A continuity plan keeps the study whole.
- Year 15Final follow-up. Data reconciled and ready for reporting.
Every year: safety capture, outreach to participants’ own providers, and data kept reconciled
Based on FDA guidance (January 2020): 15 years of follow-up for integrating vectors and up to 15 for genome editing products, typically annual exams for the first five years, then annual contact; up to 5 years for AAV vectors.
| What enrollment needs. | What follow-up needs. |
|---|---|
| Sites activated. | A site that is engaged for the long-term. |
| Participants identified and consented. | A health-literate participant, educated throughout the study and invested in the outcome. |
| Enrollment visit completed and data entered. Follow-up visit scheduled. | Contact every year or more often, by the method each participant prefers, and data that still reconciles after the sponsor’s team has turned over. |
| A validated system at launch. | A flexible platform that grows as study and participant needs change, with every change validated against the protocol and clinops standards. |
FDA’s current guidance recommends 15 years of long-term follow-up for integrating vectors, up to 15 years for genome editing products, and up to 5 years for AAV vectors. It asks sponsors to make every effort to prevent loss to follow-up.
- Outreach to participants’ own healthcare providers, so delayed adverse events reach the investigator.
- A plan for when a site closes, staff turn over, or the program changes hands.
FDA, Long Term Follow-Up After Administration of Human Gene Therapy Products, Guidance for Industry, January 2020.
Send us a message. Nurse Alicia and her team will get back to you.