Ziauddin University

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. Nida Hussain

CEO & Director
Clinical Trial Unit [email protected]

Dr.Zulfiqar Ali Umrani

Director Admin
Clinical Trial Unit [email protected]

Dr. Mirza Tasawer Baig

Director Regulatory Affair
Clinical Trial Unit [email protected]

Dr. Mansoor Ahmer Khan

Manager
Clinical Trial Unit [email protected]

Ms. Shiza Ashraf

Senoir Clinical Research Coordinator
Clinical Trial Unit [email protected]

Ms. Rimsha Ashfaq

Clinical Research Coordinator
Clinical Trial Unit [email protected]

Mr. Prashant Tikmani

Clinical Research Coordinator
Clinical Trial Unit [email protected]

Ms. Nadia Karim

Clinical Research Nurser
Clinical Trial Unit [email protected]

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Clinical Research Pharmacist
Clinical Trial Unit

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Clinical Research Phlebotomist
Clinical Trial Unit

Dr. Shireen Shah

Study Coordinator
Clinical Trial Unit [email protected]

Dr. Usama Arzoo

Research Associate
Clinical Trial Unit [email protected]

Dr. Mehrnaz Barry

Study Coordinator
Clinical Trial Unit [email protected]

Dr. Omama Ghoury

Study Coordinator
Clinical Trial Unit [email protected]

Dr. Sana Zeeshan

Study Coordinator
Clinical Trial Unit [email protected]

Dr. Hasan Zahid

Study Coordinator
Clinical Trial Unit [email protected]

Mr. Amir Khan

Data Entry Officer
Clinical Trial Unit [email protected]

Ms. Naseem Eric

Data Entry Officer
Clinical Trial Unit [email protected]

Mr. Shehriyar Khokhar

Data Entry Officer
Clinical Trial Unit [email protected]

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)

Sr. No Trial Title Principal Investigator Co-Principal Investigator
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
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 Dr. Nauman Zahir
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. Fatima.Jehangir
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 Dr. Ali Qadeer
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
6 Evaluating the use of an FDA cleared, novel vaginal speculum for gynecologic procedures Dr. Rubina Hussain Dr. Fatima Jehangir
7 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 Dr. Ali Qadeer
8 Enabling ISARIC Clinical Characterization Protocol (CCP) rollout in LMICs ISARIC funded by University of Oxford/Wellcome Trust Dr. Madiha Hashmi N/A
9 The Mega Randomized Registry Trial Comparing Conservative vs. Liberal Oxygenation Targets (Mega-ROX) funded by MRINZ Dr. Madiha Hashmi N/A
10 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
11 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
12 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
13 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
14 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
15 Genetics of Mortality in Critical Care (GenOMICC) funded by University of Edinburgh Dr. Madiha Hashmi N/A

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.

Telephone: 

+9221-35862937

Manager Extension  2448
Coordinators Extension 2451
Front Desk Extension 2450
 

Address: 

Ziauddin University,  4/B, Shahrah-e-Ghalib, Block 6, Clifton Karachi.

Email:

[email protected]