PMD Research · Independent clinical trial monitoring
Complex trials.
Experienced hands.
Work directly with Patricia M. Dunlea, a senior Clinical Research Associate with 25 years of monitoring experience and a focus on oncology, CAR-T, and cellular therapies.
The practice
A personal approach to rigorous research.
PMD Research brings experienced monitoring to your study, with direct access to the person doing the work. On-site, remote, and hybrid support is available to pharmaceutical sponsors, CROs, and staffing partners.
Where we work best
- Phase I–III oncology and cellular therapy studies
- CAR-T and NK cell therapy trials at academic and community cancer centers
- Short- and long-term contracts with sponsors, CROs, and staffing firms
Careful oversight
Monitoring informed by FDA regulations and ICH/GCP guidelines, with experience across US and Canadian sites.
Specialist experience
Hands-on experience with CAR-T and cellular gene therapy protocols, including the practical demands they place on trial sites.
Attention where it matters
A risk-based approach focused on participant safety, reliable data, and clear, timely communication with your team.
Experience with the details that make a study complex.
Tricia has monitored CAR-T and cellular gene therapy studies across academic cancer centers nationwide. That experience brings familiarity with complex protocols and the day-to-day work of the sites delivering them.
- Familiarity with the operational demands of cellular therapy trials
- An informed starting point for complex protocol review
- Experience working with oncology research teams nationwide
Working together
Let’s talk about your study.
Tell Tricia about your protocol, sites, and timing. She’ll discuss where her experience fits and the monitoring support your team needs.
- BS, Environmental Science UMass Amherst
- CAPM Certified Associate in Project Management
- ICH/GCP Certified, US & Canada
- North Easton, MA · Available Nationwide
Patricia M. Dunlea · BS, CAPM
The experience behind PMD Research.
Patricia M. Dunlea—known as Tricia—founded PMD Research to work directly with sponsors and CROs as an independent Senior Clinical Research Associate. Her 25-year career spans oncology, pulmonary disease, dermatology, and medical devices.
She has held roles with IQVIA, ICON/PRA Health Sciences, Premier Research, and Precision for Medicine. Her work has included complex site management and studies that reached database lock ahead of schedule.
Her particular focus is cellular and gene therapy, including CAR-T studies. Her experience includes studies sponsored by Pfizer, Bayer, Celgene, Kite/Gilead, Daiichi Sankyo, and NIH-funded programs.
Site Experience
Experience across academic and community research centers in the United States and Canada.
Career History
A career in clinical research.
PMD Research, LLC — Senior CRA, DCRI Contract
Managing 13 sites on a complex NIH-funded platform protocol. Completed recruitment ahead of schedule with an early database lock achieved.
IQVIA Biotech — Senior CRA III
Advanced oncology monitoring across multiple trials. Delivered an ahead-of-schedule database lock for a Phase II Head and Neck Cancer study.
Precision for Medicine — Senior Clinical Researcher
On-site and remote CAR-T monitoring across multiple studies and sponsors. Full ICH GCP/ISO14155 compliance.
Premier Research — Senior CRA, Remote
Full cycle monitoring focused on data integrity and patient safety. TMF/eTMF maintenance per ICH/GCP Section 8.
ICON Clinical Research, formerly PRA Health Sciences
Eight years as Senior CRA across Phase I through III oncology. Mentored junior CRAs and contributed to process improvement initiatives.
Quintiles, DePuy Spine and Earlier Roles
CRO, medical device, and in-vitro diagnostics work that built the regulatory and site management foundation for a 25-year career.
The practice
Thoughtful oversight.
At every stage of your study.
Contract monitoring for sponsors, CROs, and NIH-funded programs, with on-site, remote, or hybrid support.
On-Site Monitoring Visits
Site qualification, initiation, interim monitoring, and close-out visits conducted per the Clinical Monitoring Plan and ICH/GCP guidelines.
Remote Monitoring
Centralized and risk-based remote monitoring through your CTMS, eTMF, and EDC systems, with clear documentation and follow-up.
TMF Review & Maintenance
Review and maintenance of essential study documents, with attention to completeness, consistency, and ICH/GCP requirements.
Source Data Verification
Source data verification to review the accuracy, completeness, and consistency of reported trial data.
Investigational Product Accountability
IP receipt, storage, dispensing, and destruction review in full compliance with protocol and regulatory requirements.
Regulatory & Compliance Review
Review of IRB approvals, informed consent, and site regulatory files to ensure ongoing FDA and local regulatory compliance.
Tools & Systems
Comfortable in your working environment.
Experience with EDC, IVRS, CTMS, and eTMF systems, alongside clinical project management tools and Excel for monitoring metrics.
Clinical Specialty
Oncology experience.
Cellular therapy focus.
Tricia’s monitoring experience includes CAR-T and cellular gene therapy studies across blood cancers and solid tumors. Her work spans early- and later-phase trials, with attention to the distinct requirements of each protocol.
Therapeutic Areas
A focused practice. A broad clinical background.
CAR-T / CGT
Multiple myeloma, follicular lymphoma, large B-cell lymphoma, ALL/AML, and prostate cancer across autologous and allogeneic cell therapy platforms.
Solid Tumors
Head and neck, glioblastoma, NSCLC, ovarian, uterine, breast, and prostate cancers across Phase I through III studies.
Other Areas
Pulmonary including asthma and COPD, dermatology, in-vitro diagnostics, and medical devices.
Select Study Experience
Selected study experience.
| Phase | Indication | Study | Sponsor |
|---|---|---|---|
| Phase I/II · CAR-T | Prostate Cancer | PSMA-targeted CAR-T cells in metastatic castration-resistant prostate cancer | Tceleron Therapeutics |
| Phase I/II · CGT | Multiple Myeloma | bb2121 in relapsed/refractory multiple myeloma | Celgene / BMS |
| Phase I/II · CGT | Advanced Cancers | CART-TnMUC1 in TnMUC1-positive advanced cancers | Kite / Gilead |
| Phase II | Head & Neck | Evorpacept plus pembrolizumab in advanced HNSCC (ASPEN-04) | ALX Oncology |
| Phase III | Prostate Cancer | Darolutamide (Nubeqa) in high-risk non-metastatic CRPC | Bayer |
| Phase II | AML | Quizartinib versus salvage chemotherapy in FLT3-ITD positive AML (QuANTUM-R) | Daiichi Sankyo |
| Phase II | Ovarian Cancer | Carboplatin/Gemcitabine plus BSI-201 in platinum-resistant ovarian cancer | Sanofi |
Start a conversation
Your next study starts with a conversation.
Share a little about your study and the support you’re looking for. Tricia works directly with pharmaceutical sponsors, CROs, and staffing partners on contract monitoring engagements.
Send Tricia a note. She’ll respond within 1–2 business days to discuss your study and availability.