Frequently Asked Questions
1. What therapeutic areas does TKMRP specialize in for clinical research?
TKMRP specializes in kidney and metabolic diseases, with a focus on chronic kidney disease (CKD), glomerulonephritis, diabetic nephropathy, hypertension, metabolic syndrome, and dialysis/transplantation-related studies. Led by experienced nephrologists, we have an established patient population and the expertise to conduct Phase II-IV clinical trials in these areas.
What patient population does TKMRP have access to for recruitment?
As a private nephrology practice and clinical research site, TKMRP has access to a large, diverse patient pool with kidney and metabolic conditions. Our site benefits from direct referrals within our nephrology network, partnerships with local healthcare providers, and a dedicated research database of pre-screened patients. We implement targeted recruitment strategies, including physician referrals, digital outreach, and community partnerships, to optimize enrollment efficiency.
What site capabilities and research infrastructure does TKMRP offer?
TKMRP is a fully equipped research site with:
- Dedicated research space, including exam rooms and secure IMP storage.
- On-site phlebotomy, biological sample processing, and ECG capabilities.
- Secure temperature-controlled storage for IMP management and accountability.
- Access to central and specialty labs for sample analysis.
- Integration with electronic data capture (EDC) systems, IRT, and remote monitoring platforms.
A research team that includes GCP-certified PIs, CRCs, Clinical Coordinator, Chief Information Officer, study nurses, and regulatory specialists.
How does TKMRP ensure regulatory compliance and data integrity?
TKMRP strictly adheres to Good Clinical Practice (GCP), Health Canada, FDA, and ICH guidelines to maintain compliance and data integrity. Our regulatory processes include:
- Electronic regulatory document management (via Medidata, IRB platforms, etc.).
- Regular internal and external audits to ensure protocol adherence.
- Dedicated regulatory staff managing IRB/ethics submissions and site monitoring visits.
- Secure data handling and quality control measures to maintain research integrity.
What is TKMRP’s experience with previous clinical trials?
TKMRP has successfully conducted Global Phase II-IV nephrology and metabolic disease trials, collaborating with pharmaceutical sponsors, CROs, and biotech companies. Our Principal Investigator, Dr. Bajinder S. Reen, MD, FRCP(C), has extensive experience in clinical research, patient recruitment, and regulatory compliance. We have a strong track record of meeting enrollment targets, retaining patients, and producing high-quality data for our industry partners.
How quickly can TKMRP initiate a new study and begin enrollment?
Our site is structured for rapid study startup, with an efficient regulatory process and pre-screened patient population. We typically achieve:
- Regulatory and IRB approvals within 30-60 days, depending on protocol complexity.
- Feasibility and site qualification within 1-2 weeks.
- First patient screening within 4-6 weeks post-activation.
Our dedicated research team ensures swift contract execution, staff training, and seamless trial integration, minimizing delays and optimizing study timelines.
What support does TKMRP provide to CROs and sponsors during study execution?
TKMRP is committed to seamless collaboration with CROs and sponsors by providing:
- Dedicated Study Coordinators who serve as primary liaisons, ensuring smooth communication.
- Rapid responsiveness to queries, monitoring visits, and data requests.
- Full integration with sponsor-selected technology platforms (EDC, IRT, eConsent, etc.).
- Regulatory and protocol adherence support, including assistance with amendments and data reconciliation.
- Detailed patient tracking and reporting, including real-time enrollment updates and retention strategies.
We prioritize sponsor satisfaction, compliance, and efficiency, ensuring that study timelines and quality metrics are consistently met.
What makes TKMRP an ideal site for CROs looking to expand their investigator network?
TKMRP offers a unique combination of expertise, infrastructure, and patient access, making us an ideal investigator site for CROs. Key advantages include:
- Nephrology-Focused Private Practice – Direct access to highly engaged patients with kidney and metabolic conditions.
- Experienced Research Team – Led by Dr. Bajinder S. Reen, MD, FRCP(C), an established nephrologist with clinical trial leadership experience.
- Advanced Site Capabilities – Full IMP management, lab processing, ECG, ePRO, and hybrid trial capabilities.
- Proven Track Record – Strong history of meeting enrollment targets and data quality expectations for sponsors.
- Scalability & Speed – Fast study startup with a dedicated regulatory team ensuring efficient feasibility assessments, contract execution, and site activation.
For CROs looking for reliable, high-performing investigator sites, TKMRP provides clinical excellence, operational efficiency, and sponsor-focused trial execution.
Do you have a specific question? Submit your question and we will do our best to answer it!
The Kidney and Metabolic Research Partners is a premier clinical research facility specializing in kidney and metabolic disease trials. Our site provides turnkey clinical trial services, offering sponsors and CROs a highly experienced research team, access to a diverse patient population, and a fully equipped research facility.
TKMRP is committed to excellence in patient care, regulatory compliance, and data integrity.
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