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Who We Are
Labmark is a trusted Tanzania-headquartered Clinical Research Organization (CRO)
recognized for its leadership in clinical research, epidemiology, and regulatory solutions, with
a specialized focus on in-vitro diagnostics (IVD) and medical devices.
We combine rigorous
scientific expertise, deep understanding of the local context, and adherence to global
standards to ensure quality, integrity, and impact in every project. As a credible partner, we
are committed to accelerating the availability of safe, effective, and innovative health
technologies that advance patient care and strengthen health systems.
What We Do
Clinical Research
We offer a full spectrum of clinical research services, including protocol development, site selection, study initiation, monitoring, data management, and medical writing. Our expertise encompasses clinical investigations and Post-Market Clinical Follow-up (PMCF) studies, ensuring robust evidence generation aligned with international standards.
Epidemiology & Real-World Evidence (RWE)
Our team designs and conducts observational studies, establishes patient registries, and performs burden-of-disease and effectiveness evaluations. These services provide critical insights to support regulatory submissions, market access, and strategic decision-making.
Regulatory & Quality Affairs
We deliver regulatory strategy, submission support, Quality Management System (QMS) implementation, and post-market surveillance services tailored for IVDs and medical devices. All activities are aligned with international standards to ensure compliance, safety, and reliability.
Laboratory Testing & Validation
Through strategic partnership with ISO-accredited local laboratories, we provide laboratory testing and validation services to ensure the performance and reliability of medical devices and IVDs. By leveraging established labs that adhere to rigorous quality standards, we help our clients meet regulatory requirements and verify product efficacy without the need for in- house laboratory facilities.
Training &
Capacity Building
We offer specialized training programs aimed at enhancing the skills and knowledge of healthcare professionals and stakeholders in the medical device and IVD sectors. Our training initiatives are designed to foster capacity building and ensure adherence to best practices in the industry.
Our Values
Integrity
We uphold the highest standards of honesty, transparency, and accountability in all our actions, ensuring trust and confidence among our partners and stakeholders.
Excellence
We are committed to delivering solutions that meet global standards of quality and rigor, while thoughtfully adapting to the local context to achieve meaningful impact.
Partnership
We cultivate long-term, collaborative relationships with clients, regulators, and stakeholders, fostering innovation and expanding access to safe and effective health technologies.
Innovation
We embrace creativity and scientific rigor to develop forward-thinking solutions that address evolving healthcare challenges and support our clients’ success.
Impact
We strive to make a tangible difference in healthcare delivery by enabling safe, effective, and accessible medical innovations that improve patient outcomes and strengthen health systems.