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
Clinical Trial Unit
The Ziauddin Clinical Trial Unit is dedicated to conducting high-quality clinical trials across various therapeutic areas, adhering to international regulatory standards, and collaborating with researchers, clinicians, and industry partners. It serves as a dynamic hub where healthcare professionals, researchers, and industry experts collaborate to address crucial medical challenges and drive medical advancements. Equipped with cutting-edge infrastructure, dedicated facilities, and advanced technology, the CTU provides an optimal environment for rigorous trial execution and reliable clinical data generation. Upholding ethical guidelines, regulatory compliance, and participant safety is paramount, fostering trust among participants, sponsors, and the wider medical community. Through this prospectus, the CTU invites researchers, sponsors, and industry partners to collaborate and leverage its resources, offering comprehensive services throughout the clinical trial lifecycle. With a vision to contribute to scientific discoveries, enhance patient care, and shape the future of medical research and innovation, the Ziauddin Clinical Trial Unit aims to be at the forefront of clinical research.
The Clinical Trial Unit at Ziauddin was established in 2022 and holds recognition from the Drug Regulatory Authority of Pakistan (DRAP). This recognition by DRAP highlights the unit’s compliance with regulatory standards and its commitment to conducting clinical trials in accordance with national guidelines. As an officially recognized clinical trial unit, Ziauddin is well-positioned to contribute to the advancement of medical research and innovation in Pakistan. By adhering to DRAP regulations, the unit ensures that all trials conducted within its facilities follow the necessary ethical and safety guidelines, thereby maintaining the integrity of the research process and protecting the well-being of trial participants.
The Clinical Trial Unit at Ziauddin aims to conduct high-quality clinical trials, develop innovative therapies, contribute to evidence-based medicine, enhance patient care, and foster a culture of research and innovation among healthcare professionals.
Welcome to the Ziauddin University Clinical Trials Unit website. At Ziauddin University, we are committed to providing excellence in clinical research and evidence-based interventions, which is why we are proud to introduce our Clinical Trials Unit. By leveraging the expertise of our faculty and staff, the Clinical Trials Unit provides our university community with a state-of-the-art platform for conducting clinical trials. We are dedicated to providing the highest quality research services and resources to our clients and partners. The Clinical Trials Unit is committed to helping our partners achieve their research goals while working in a safe, secure, and compliant environment. Our team of dedicated professionals is available to answer questions and provide guidance to ensure that clinical trials are conducted in accordance with the highest ethical standards. We invite you to explore our website to learn more about the Clinical Trials Unit and its services. We look forward to working with you to advance the science of clinical research and evidence-based interventions.
Dr.Nida Hussain
CEO Clinical Trial Unit
Ziauddin University
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).
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.
Dr.Zulfiqar Ali Umrani
Director Admin/ORIC [email protected]
Dr. Madiha Hashmi
Director Clinical Operations [email protected]
Dr. Mirza Tasawer Baig
Director Regulatory Affair [email protected]
Dr. Ashok Kumar
Co-Director Clinical Operations [email protected]
Mansoor Ahmer Khan
Manager CTU [email protected]
Ms. Sidra Tayyab
Manager Quality Assurance [email protected]
Dr. Sana Ansari
Manager Quality Control
Ms. Sana Kanwal
Manager Medical Record [email protected]
Mr. Fahad Ali
Manager IT [email protected]
Dr. Farah Naz
Clinical Pharmacist [email protected]
Ms. Aasma Moin Khan
Study Coordinator [email protected]
Dr. Arishay Hussaini
Study Coordinator [email protected]
Mr. Adnan Gul
Data Entry Officers
Mr. Akash Thakrani
Data Entry Officers
Clinical
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)
ACORN-HAI
Clinically-Oriented Antimicrobial Resistance Surveillance
Network for Healthcare-associated
(Funded by National University of Singapore/Wellcome Trust)
GenOMICC
Genetics of Mortality in Critical Care
(Funded by University of Edinburgh)
ISARIC
Enabling ISARIC Clinical Characterization Protocol (CCP) rollout in LMICs
(Funded by University of Oxford/Wellcome Trust)
MM Vs. N95
Medical Masks versus N95 respirators to prevent 2019 Novel Coronavirus Disease (COVID-19 N95 Vs MM)
(Funded by McMaster University)
MegaRox
The Mega Randomized Registry Trial Comparing Conservative vs. Liberal Oxygenation Targets
(Funded by MRINZ )
O2CoV2
Oxygen requirements and approaches to respiratory support in patients with COVID-19 in low- and middle-income
countries.
(Funded by WHO)
REMAP-CAP
Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia including COVID 19
(REMAP CAP+ Pandemic) in Pakistan.
(Funded by Monash University)
Recovery
Randomized Evaluation of COVID-19 Therapy
ISRCTN: ISRCTN50189673 EU Clinical Trials Register: EudraCT 2020-001113-21
Clinical Trials.gov: NCT04381936 RECOVERY)
(Funded by University of Oxford)
Sr. No | Trial Title | Principal Investigator | Co-Principal Investigator | Funding Amount | Status |
| 1 | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19 | Dr. Nida Hussain | Dr. Ashok Kumar | $110,000 | Starting in July |
| 2 | A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer | Dr. Adnan Abdul Jabbar | N/A | $330,000 | Recently approved |
| 3 | A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies Vaccine (Vero cell) for human use, freeze-dried in Healthy Adults using a Post Exposure Prophylaxis Schedule | Dr. Osama Rehman Khalid | Dr. Ashok Kumar | $375,000 | Sponsor visit in July |
| 4 | 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 | Dr. Zaigham Abbas | N/A | $100,000 | Expected enrollment to start by August |
| 5 | A multicenter, open-label, randomized, phase III clinical trial to evaluate efficacy and safety of XXX versus imatinib at 600 or 800 mg daily in adult patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) resistant to imatinib at daily doses of 400 or 600 mg | Dr. Amna Qamar us Zaman | N/A | $90,000 | Recently conducted site selection visit |
| 6 | A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis | Dr. Zaigham Abbas | N/A | TBD | TBD |
| 7 | Evaluating the use of an FDA cleared, novel vaginal speculum for gynecologic procedures | Dr. Rubina Hussain | Dr. Fatima Jehangir | $1,500 | Study completed |
| 8 | A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy with BCD-264 and Darzalex® in Subjects with Relapsed and Refractory Multiple Myeloma | Dr. Amna Qamar Us Zaman | N/A | TBD | Site selection visit pending |
| 9 | A Phase 3 study, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of investigational Influenza Vaccine Compared to a High-Dose Quadrivalent Influenza Vaccine (Fluzone HD) in adults ≥ 65 Years of Age | Dr. Abbas Zafar | Dr. Uzma Ghouri | TBD | Site selection visit pending |
| 10 | 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 | Dr. Zaigham Abbas | N/A | TBD | Site has been selected |
| 11 | Enabling ISARIC Clinical Characterization Protocol (CCP) rollout in LMICs ISARIC funded by University of Oxford/Wellcome Trust | Dr. Madiha Hashmi | N/A | GBP 48,674.08 | Successfully going to end by 2023 |
| 12 | The Mega Randomized Registry Trial Comparing Conservative vs. Liberal Oxygenation Targets (Mega-ROX) funded by MRINZ | Dr. Madiha Hashmi | N/A | TBD | Study on going |
| 13 | Randomized Evaluation of COVID-19 Therapy ISRCTN: ISRCTN50189673 EU Clinical Trials Register: EudraCT 2020-001113-21 Clinical Trials.gov: NCT04381936 RECOVERY) funded by University of Oxford | Dr. Madiha Hashmi | N/A | PKR 1,239,290 | Study completed |
| 14 | Medical Masks versus N95 respirators to prevent 2019 Novel Coronavirus Disease (COVID-19 N95 Vs MM) funded by McMaster University | Dr. Madiha Hashmi | N/A | $ 205,700 | Study completed |
| 15 | Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia including COVID 19 (REMAP CAP+ Pandemic) in Pakistan (REMAP-CAP) funded by Monash University | Dr. Madiha Hashmi | N/A | AUD 83,142.40 | Study completed |
| 16 | Oxygen requirements and approaches to respiratory support in patients with COVID-19 in low- and middle-income countries (O2CoV2) funded by WHO | Dr. Madiha Hashmi | N/A | $ 10,901 | Study completed |
| 17 | Clinically-Oriented Antimicrobial Resistance Surveillance Network for Healthcare-associated (ACORN-HAI) funded by National University of Singapore / Wellcome Trust | Dr. Osama Rehman Khalid | N/A | SGD 79,530 | Patient enrollment is ongoing |
| 18 | Genetics of Mortality in Critical Care (GenOMICC) funded by University of Edinburgh | Dr. Madiha Hashmi | N/A | TBD | Study on going |
Telephone:
+9221-35862937 ext 2359
Address:
Ziauddin University, 4/B, Shahrah-e-Ghalib, Block 6, Clifton Karachi.
Email: