Clinical Trial Unit
The Ziauddin University Clinical Trials Unit (ZU CTU), Approved in 2022 and formally recognized by the Drug Regulatory Authority of Pakistan (DRAP), is committed to conducting high-quality Phase II, III and IV clinical trials in alignment with national and international regulatory standards. With advanced infrastructure, dedicated facilities, and a multidisciplinary research team, ZU CTU provides a robust platform for ethical, efficient, and participant-centered trial execution across a broad range of therapeutic areas. The unit operates under stringent ICH-GCP compliance and prioritizes data integrity, patient safety, and operational transparency.
A defining feature of ZU CTU is its pioneering Patient & Public Involvement and Engagement (PPIE) Group—the first of its kind in Pakistan. This initiative ensures that patients, caregivers, and community members are meaningfully involved in the research process, from shaping protocols and reviewing consent forms to contributing to outcome dissemination. The PPIE group reflects a shift toward more inclusive and ethically sound research practices, aligning with global patient engagement standards and demonstrating Ziauddin’s leadership in community-integrated clinical research.
In its pursuit of excellence, the Clinical Trials Unit is also engaged with the WHO-supported Clinical Trials Unit Maturity Framework led by the Global Health Network and the Centre for Clinical Research Governance (CCRG) at the University of Oxford. Through this collaboration, ZU CTU benchmarks its institutional capacity against global maturity indicators covering governance, data systems, staffing, and trial conduct quality ensuring continuous improvement and positioning itself as a competitive and reliable research site both nationally and internationally.
As a research-driven institution, Ziauddin University invites collaboration with academic investigators, pharmaceutical sponsors, and contract research organizations (CROs) to accelerate innovation and improve health outcomes. With a vision to contribute meaningfully to scientific discovery and patient-centered care, the Clinical Trials Unit stands as a model for excellence in ethical, impactful clinical research in Pakistan.
Ongoing Trials
| Title | Protocol No. | Status |
| “An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects with Relapsed/Refractory Multiple Myeloma” | BCD-248-2/FLAMMINGO | Active, Recruiting |
| Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) versus Keytruda® in Combination with Chemotherapy for the Treatment of Patients with Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study) | MB12-C-02-24 | Active, Recruiting |
| A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1) | VIR-CHDV-203 | Active, Recruiting |
| A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1) | VIR-CHDV-203 | Active, Recruiting |
| A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy versus Bulevirtide in Participants with Chronic HDV Infection (ECLIPSE 3) | VIR-CHDV-206 | Active, Recruiting |
| An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 | AT-01B-008 | Active, Recruiting |
| A phase III, Randomized, comparator-controlled, double-blind, Multicenter study to evaluate the immunogenicity,safety and lot to lot consistency of three lots of PIKAÂ Rabies Vaccine( Vero cell) for Human use, Freeze-dried in healthy adults using a post-Exposure prophylaxis schedule. | YS-002 | Active, Not Recruiting |
| A multicenter, randomized, controlled, open-label, phase IIb study to assess efficacy and safety of HH-003 injection in subjects with chronic hepatitis delta virus infection. | HH003-204 | Active, Not Recruiting |
| A Phase 2, Open-Label Study to assess the safety and efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in subjects with Chronic Hepatitis C Virus (HCV) Infection” | AT-01B-004 | Active, Not Recruiting |
| A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer | BCD-178-2/PREFER | Active, Not Recruiting |
| “A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID -19. | AT-03A-017 | Completed |
Dr. Nida Hussain- CEO- CTU
At Ziauddin University, the Clinical Trials Unit represents more than just a research facility — it reflects our institutional vision to drive excellence in health sciences through innovation, ethics, and impact.
As CEO of the CTU, I am proud to witness how this unit has evolved into a national leader in regulated, patient-centered clinical trials. Our pioneering adoption of global frameworks, such as the WHO CTU Maturity Metrics and the establishment of Pakistan’s first PPIE group, demonstrates our commitment to both scientific and societal progress. We are deeply invested in creating a research culture that is inclusive, globally competitive, and aligned with the real needs of our communities.
We look forward to expanding our partnerships and deepening our research footprint — locally, nationally, and internationally — as we continue our pursuit of advancing evidence-based care and shaping the future of medicine in Pakistan.
Dr. Zulfiqar Ali Umrani- Director-CTU
Welcome to the Ziauddin University Clinical Trials Unit (ZU CTU). As Director, I am honored to oversee a growing research platform that exemplifies scientific rigor, operational excellence, and ethical commitment. Our CTU stands at the forefront of clinical research in Pakistan, driven by a team of highly skilled professionals dedicated to conducting trials that meet the highest international standards. We take immense pride in our strong regulatory compliance, robust patient engagement practices, and an unwavering focus on data quality and participant safety.
Through strategic collaborations, capacity building, and transparent processes, we aim to strengthen the national research ecosystem while enabling transformative discoveries that benefit patients and society at large. We welcome investigators, sponsors, and partners to join us in our shared mission to accelerate innovation and advance the future of healthcare.
Mansoor Ahmer Khan- Manager CTU
Welcome to the Clinical Trial Unit (CTU). As the Manager of CTU, I am proud to lead a dedicated team committed to advancing clinical research through excellence, integrity, and collaboration. Our mission is to support high-quality, ethically sound clinical trials that contribute to evidence-based medical practices and improved patient outcomes.
At CTU, we provide comprehensive support to investigators and sponsors throughout the clinical research process — from protocol development and regulatory submissions to data management and study monitoring. We are driven by a commitment to innovation, compliance with international standards, and the pursuit of research that makes a meaningful difference in healthcare.
We invite researchers, collaborators, and partners to connect with us as we continue to build a robust and sustainable research environment. Together, we strive to make a lasting impact on public health and medical science.
Dr Mirza Tasawer Baig - Director Regulatory Affairs / Clinical Pharmacist
At the heart of every successful clinical trial lies a foundation built on ethical rigor, regulatory compliance, and patient safety. As Director of Regulatory Affairs and a Clinical Pharmacist at the Ziauddin Clinical Trials Unit, I am proud to support a research environment where these principles are not only upheld—but deeply embedded in every stage of our trial processes.
Our regulatory affairs division ensures that all studies conducted at CTU adhere strictly to ICH-GCP guidelines, national regulations, and sponsor-specific requirements. We work closely with investigators, sponsors, ethics committees, and government agencies to facilitate smooth approvals, ethical oversight, and transparent reporting. As a Clinical Pharmacist, I am also deeply committed to ensuring safe investigational drug handling, accountability, and pharmacy-driven clinical support that enhances both data quality and participant care.
Together, we strive to uphold the highest standards in clinical research while building trust with patients, regulators, and collaborators alike. At ZU CTU, compliance is not just a responsibility—it’s our promise to science and society.
VISION
The Clinical Trials Unit aims to conduct clinical trials that help Sponsors and collaborators to develop new medications and new indications for existing medications for a variety of disorders over a wide spectrum of clinical areas. At the same time, helping our patients and clinical trial participants discover new and effective therapies for their conditions where other existing therapies have been unsuccessful.
MISSION
To execute clinical trials effectively and competently in clinical research in line with the International Directives for Clinical Trial Research (Declaration of Helsinki, ICH, and GCP Guidelines).
Ms Nadia Karim
Mr Rumail Shahzad
Taha Abbasi
Mr Syed Wahaj
Dr Tasneem Rashid
Dr Lubna Sohail
Clinical
Equipped examination rooms, consultation rooms, Separate Consent room and assessment rooms
Infusion and cardiac monitoring
Protocol-related specimen collection, processing, and handling; specimen collection restrooms
Management of experimental products linked to protocols
Dedicated space for investigators to work during research clinics
Reception, check-in, and waiting area
Nutrition support – study subjects, approved access per protocol (fasting, long-stay)
Safe Waste Disposal
Equipment
Standard – bed Units with oxygen, vacuum; infusion pumps, and vitals monitors
-20C & -80C freezer’s
On-site ECG tracing services and Cardiac monitoring capability
Equipped and medically stocked emergency cart
Audio and visual call system
All clinical and consulting rooms are provided with a wireless Internet connection and secure Computers and computer systems.
Administrative
Audio-conference facilities to facilitate collaborations
workspaces for study coordinators
Procedure room with four beds, an emergency trolley, and IV infusion supplies
Secure Document/data storage room
Data entry and data management services
Support services – printing, copying, and other
Specialized monitoring area
Hazard monitoring command center
Fire emergency system (Fire Alarm, Fire extinguisher and Fire proof cabinets)
At CTU, we provide end-to-end support for the design, execution, and management of clinical trials. From regulatory compliance and protocol development to data monitoring and reporting, our goal is to facilitate high-quality, ethical, and impactful research. We are proud to support a diverse range of clinical studies in collaboration with national and international partners.
Ziauddin University fosters a culture of research-driven learning and clinical excellence, and the CTU plays a critical role in transforming novel ideas into evidence-based practices that benefit patients and society.
Patient & Public Involvement and Engagement (PPIE)
The Patient & Public Involvement and Engagement (PPIE) Group is an integral part of the Ziauddin University Clinical Trials Unit’s (ZU CTU) commitment to conducting inclusive, ethical, and community-driven research. As the first formally structured PPIE group in Pakistan, it represents a groundbreaking step in embedding patient and public voices into the clinical research lifecycle—ranging from study design and consent development to participant communications and feedback mechanisms.
This pioneering initiative has contributed significantly to improving research transparency, enhancing participant trust, and aligning studies more closely with real-world needs. Its collaboration with ZU CTU has set a national precedent, demonstrating how involving patients and communities can raise the quality, relevance, and impact of clinical trials.
Looking ahead, ZU CTU is proud to lead efforts to scale this model across other Clinical Trials Units nationally, with the aim of building a unified culture of patient involvement in Pakistan’s research infrastructure. The ongoing synergy between CTU and the PPIE group reflects our shared vision—to make clinical research not just scientifically sound, but also socially responsive and community-led
Click Here: https://zu.edu.pk/ppie/
CTU Maturity Framework
Ziauddin University is proud to be among the first institutions in Pakistan partnering with the World Health Organization (WHO) and the University of Oxford’s Centre for Clinical Research Governance (CCRG) to implement the CTU Maturity Framework—a globally recognized model designed to elevate the quality and effectiveness of clinical trial units. This collaboration reflects Ziauddin’s leadership in advancing research standards and its unwavering commitment to international best practices.
Through this partnership, the Ziauddin Clinical Trials Unit is systematically aligning its operations with global benchmarks across key domains such as governance, infrastructure, quality assurance, trial delivery, and stakeholder engagement. The CTU Maturity Framework not only guides the continuous strengthening of our systems, but also positions Ziauddin University as a model of excellence for other emerging research institutions in the region.
As we implement this framework, our goal is to establish a resilient, self-sustaining clinical research infrastructure that meets the highest international standards—enabling us to lead multi-center trials, attract global partnerships, and contribute meaningfully to the advancement of healthcare in Pakistan and beyond.Â
Click Here: https://zu.edu.pk/ccrg/
Achivements
The Clinical Trial Unit at Ziauddin University has consistently demonstrated excellence in advancing medical research and participant recruitment, solidifying its position as a key player in the field of clinical trials. Remarkably, in the Bouquet Speculum Trial, the Clinical Trial Unit showcased its exceptional efficiency by successfully enrolling a substantial cohort of 160 participants within just one month. This achievement not only underscores the unit’s dedication to expediting the trial process but also speaks to its ability to efficiently engage and enroll participants promptly.
In the Rabies Trial, the unit achieved a significant milestone by surpassing expectations and recruiting 303 patients in less than a month. This accomplishment is a witness to the Clinical Trial Unit’s agility and effectiveness in assembling a diverse and sizable participant pool for crucial research on rabies. The speed and success with which the recruitment process was conducted reflect the unit’s commitment to addressing urgent healthcare challenges and contributing valuable data to advance our understanding of diseases.
Moreover, the unit’s recognition as the fastest recruitment for the Hepatitis D trial across Pakistan further solidifies its leadership in the clinical research landscape. Outpacing other research centers in the country, the Clinical Trial Unit has demonstrated efficiency and a commitment to making substantial contributions to medical knowledge and improving healthcare outcomes.
Collaborations & Partnerships
Telephone:Â
+9221-35862937
Address:Â
Ziauddin University,  4/B, Shahrah-e-Ghalib, Block 6, Clifton Karachi.
Email:
Ziauddin University celebrated Clinical Trial Unit Day, highlighting the pivotal role of clinical research in advancing healthcare. The event showcased ongoing trials, research ethics, and the contributions of the CTU team towards evidence-based medical practices.Â
