Welcome to the Clinical Research Centre, where innovation, ethics, and dedication drive our mission to advance healthcare. We are committed to conducting groundbreaking research that not only transform lives but does so with the utmost integrity and respect for the individuals and communities we serve.
Through collaborative efforts with researchers, healthcare professionals, and industry leaders, we strive to pioneer solutions to the world’s most pressing medical challenges. Embracing cutting-edge technologies like artificial intelligence, we aim to enhance precision, accelerate timelines, and uphold the highest ethical standards in clinical trials, ensuring that our work remains patient-centered and socially responsible.
Prof. Dr. Maimoona Siddiqui
Director, SCRC & Medical Education
Professor of Neurology, Shifa College of Medicine, Shifa Tameer-e-Millat University, Islamabad
Our Mission
To provide an unparalleled platform in the region, uniquely positioned to lead impactful, and ethical clinical research that transforms clinical practice on a global scale.
Our Vision
To be a regional leader in innovative and groundbreaking clinical research, to advance medical knowledge (“Illaman Nafian”), and to improve the well-being of the community at large by fostering collaboration among researchers, clinicians, and industry partners.
SCRC functions as a comprehensive “one‑stop shop” for clinical research, managing:
Feasibility assessments
PI selection & team assembly
IRB applications and negotiations
Patient enrollment and follow‑ups
Adverse event monitoring and trial close‑out
Equipped with dedicated Clinical Trial Units, phlebotomy areas, inpatient facilities, and a trial repository, SCRC supports diverse therapeutic trials and operational excellence
Feasibility
Site invited to assess scientific and operational viability of the proposed study
Site Selection Visit
Sponsor/CRO visits the site to evaluate its suitability based on standard data shared
IRB Submission
Protocol reviewed by IRB to ensure ethics and human subject protect
NBC Submission
National Bioethics Committee reviews protocol for national-level ethical compliance
Clinical Trial Agreement
Legal agreement signed between sponsor/CRO and SCRC; financial/logistical terms finalized
DRAP Submission
Protocol submitted to Drug Regulatory Authority of Pakistan for regulatory approval
Site Activation
Trial site is activated post-DRAP approval; all initiation activities begin
DSMB Monitoring
Data & Safety Monitoring Board provides ongoing oversight for safety & protocol compliance
| Sponsors | Trial Names | Status |
|---|---|---|
 | HALT-IT Hemorrhage alleviation with tranexamic acid-intestinal system, Tranexamic acid of the treatment of gastrointestinal bleeding: An International randomized, double-blind placebo-controlled trial. | Completed Published in Trials |
 | CRASH-3 Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomized, placebo-controlled trial | Completed Published in The Lancet |
 | HIP ATTACK 1 Accelerated surgery versus standard care in hip fracture an international, randomized, controlled trial | Completed Published in The Lancet |
 | SafeHer Study A phase-III Prospective, two-cohort non-randomized Multicenter, Multinational, open-label study to assess the safety of assisted- and self-administered subcutaneous Trastuzumab as therapy in patients with operable her2-positive early breast cancer | Completed |
 | PERUSE Study A phase III prospective, two-cohort non-randomized, Multicenter, Multinational, open-label single arm study of pertuzumab in combination of as THERAPY in patients with operable Her2-positive early breast cancer | |
 | POISE-3 Perioperative Ischemic Evaluation-3 | Completed Published in PubMed, NEJM |
 | Can Sino Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above | Completed Published in The Lancet |
 | COP-AF Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery | Completed Published in The Lancet, PubMed, European Society of Cardiology |
 | Livzon Global Phase 3 Randomized Trial to evaluate efficacy, safety, immunogenicity of Recombinant SARS COV-2 fusion protein vaccine against COVID 19 in healthy adults after vaccination of 2 doses of inactivated vaccines | Completed Published in Emerging Microbes & Infections |
 | DEPOSITION Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery | |
 | SEQIRUS A Phase III, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus’ Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine when Administrated in Healthy Subjects aged 6 Months through 47 Months | |
 | BCD-201 A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201(JSC BIOCAD) and Keytruda® in Patients with Unresectable or Metastatic Melanoma | |
 | GATES-MRI-301 A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the effect of Bi-26 (strain ofBifidobacterium longum, B. infantis) supplementation versus placebo on weight gain in underweight infants | |
 | ALVOEYE A Randomized, Double-masked, Parallel-group, MulticenterClinical Study to Evaluate the Efficacy and Safety of AVT06Compared with EU-Eylea® in Subjects with Neovascular (wet)Age-related Macular Degeneration | |
 | ASPIRE-AF Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery | In Progress |
 | BCD-178-2 A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer | Completed |
 | HIP ATTACK-2 Accelerated surgery versus standard care in hip fracture an international, randomized, controlled trial | In Progress |
 | DARVIVA/ BCD-264-2 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 | In Progress |
 | LIMIT To assess the feasibility of a large trial to evaluate the safety and efficacy of a common, lower INR target range in patients with bileaflet aortic mechanical valves. | In Progress |
 | THE SHIPPS STUDY A multi-institutional, prospective, controlled, randomized, double-blinded interventional trial to examine the potential benefits and risks of adjunctive hydrocortisone in Paediatric Septic shock. | In Progress |
BENITO 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) | In Progress | |
 | ATEA 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 Randomized, Controlled, Open-label Study” | In Progress |
| Sponsors | Trial Names | Status |
|---|---|---|
| HALT-IT Hemorrhage alleviation with tranexamic acid-intestinal system, Tranexamic acid of the treatment of gastrointestinal bleeding: An International randomized, double-blind placebo-controlled trial. | Completed Published in Trials |
| CRASH-3 Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomized, placebo-controlled trial | Completed Published in The Lancet |
| HIP ATTACK 1 Accelerated surgery versus standard care in hip fracture an international, randomized, controlled trial | Completed Published in The Lancet |
| SafeHer Study A phase-III Prospective, two-cohort non-randomized Multicenter, Multinational, open-label study to assess the safety of assisted- and self-administered subcutaneous Trastuzumab as therapy in patients with operable her2-positive early breast cancer | Completed |
| PERUSE Study A phase III prospective, two-cohort non-randomized, Multicenter, Multinational, open-label single arm study of pertuzumab in combination of as THERAPY in patients with operable Her2-positive early breast cancer | |
| POISE-3 Perioperative Ischemic Evaluation-3 | Completed Published in PubMed, NEJM |
| Can Sino Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above | Completed Published in The Lancet |
| COP-AF Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery | Completed Published in The Lancet, PubMed, European Society of Cardiology |
| Livzon Global Phase 3 Randomized Trial to evaluate efficacy, safety, immunogenicity of Recombinant SARS COV-2 fusion protein vaccine against COVID 19 in healthy adults after vaccination of 2 doses of inactivated vaccines | Completed Published in Emerging Microbes & Infections |
| DEPOSITION Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery | |
| SEQIRUS A Phase III, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus’ Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine when Administrated in Healthy Subjects aged 6 Months through 47 Months | |
| BCD-201 A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201(JSC BIOCAD) and Keytruda® in Patients with Unresectable or Metastatic Melanoma | |
| GATES-MRI-301 A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the effect of Bi-26 (strain ofBifidobacterium longum, B. infantis) supplementation versus placebo on weight gain in underweight infants | |
| ALVOEYE A Randomized, Double-masked, Parallel-group, MulticenterClinical Study to Evaluate the Efficacy and Safety of AVT06Compared with EU-Eylea® in Subjects with Neovascular (wet)Age-related Macular Degeneration | |
| ASPIRE-AF Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery | In Progress |
| BCD-178-2 A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer | Completed |
| HIP ATTACK-2 Accelerated surgery versus standard care in hip fracture an international, randomized, controlled trial | In Progress |
| DARVIVA/ BCD-264-2 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 | In Progress |
| LIMIT To assess the feasibility of a large trial to evaluate the safety and efficacy of a common, lower INR target range in patients with bileaflet aortic mechanical valves. | In Progress |
| THE SHIPPS STUDY A multi-institutional, prospective, controlled, randomized, double-blinded interventional trial to examine the potential benefits and risks of adjunctive hydrocortisone in Paediatric Septic shock. | In Progress |
BENITO 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) | In Progress | |
| ATEA 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 Randomized, Controlled, Open-label Study” | In Progress |
End-to-End Clinical Trial Support
Full-service site management: PI selection, IRB approvals, recruitment, monitoring, and regulatory compliance.
Expert Team
Led by Prof. Dr. Maimoona Siddiqui, the team includes certified research associates, biostatisticians, pharmacists, coordinators, and trained research nurses.
Global Research Standards
All operations follow Good Clinical Practice (GCP) and Joint Commission standards to ensure data integrity and patient safety.
Proven Track Record
Successfully conducted high-impact international trials.
Purpose-Built Facilities
Dedicated clinical trial units, phlebotomy stations, inpatient access, and secure repositories support both inpatient and outpatient studies.
SCRC maintains a hospital-based cancer registry established in 2018, with data from over 19,000 patients (2018–2024). Its primary objective is to ensure accurate, complete, and high-quality cancer data to support clinical care and oncology research. The registry follows international standards and plays a vital role in improving cancer surveillance, treatment outcomes, and prevention strategies.
The registry adheres to globally recognized classification and staging systems:
ICD-O-3.2 (2021 update) for coding cancer site (topography), type (morphology), and grade
AJCC TNM Staging - Preferred for clinical decision-making and treatment
SEER 2000 Summary Staging - Used for broad site coverage, including brain and lymphomas
MP 2007 SEER Manual - Applied for identifying multiple primaries
These tools ensure consistency, comparability, and reliability of cancer data across departments and over time.
Lead Biostatistician
Mehwish Rafique is a PhD scholar in public health and epidemiology, having completed an MPhil in Applied Statistics and various international clinical research courses at NIH, USA, with a focus on biomedical ethics. She is working primarily on International Clinical trials, research facilitation service, Postgraduate trainee research core competency program, research workshop presentation, statistical aspect of cancer registry annual data and data & safety monitoring board. She mainly covers the fundamental principles of application of theories of measurement, statistical inference, proportional incidence and limit the effects of chances to contribute to better clinical decisions and ultimately better prediction of health outcomes and guidance on how to go about the appropriate care of patients.
Senior Clinical Research Associate
Dr. Sofia Khan graduated from Hebei united university China in 2015. She gained clinical experience for three and half years in cardiology department (SIH). Now she is serving as a cardiology clinical research associate in SCRC and supervising and managing all the clinical trials related to cardiology.
Senior Clinical Research Associate
Dr. Sundus Dadan completed her MBBS from Shifa Medical College. She has vast experience in conducting COVID-19 vaccination trials and has been pivotal in enrolling thousands of participants in SCRC's CanSino and Livzon projects. She has been working on initiation of various clinical trials at SCRC and holds expertise in clinical trials' administrative, logistical and financial aspects.
Senior Biostatistician
Maliha Aziz is a Ph.D. scholar, having a distinction in her MS (Statistics) degree from the International Islamic University. She provides academic research facilitation to post-graduate students and consultants and assists as a data analyst in the cancer registry. For the Shifa Center of Professional Excellence, she serves as a facilitator for research training sessions and delivers lectures on biostatistics at Shifa Tameer-e-Millat University. As a Data Safety and Monitoring Board member, she plays a key responsibility for data safety and protocol adherence in all clinical trials.
Senior Research and Regulatory Pharmacist
Dr. Raja Waseem (R.ph) serves as a Senior Research and Regulatory Pharmacist at SCRC, holding a Doctor of Pharmacy from Shifa Tameer-e-Millat University, Islamabad, and pursuing a Master of Science in Public Health (MSPH) at the Health Services Academy. Within a JCI-accredited hospital environment, he demonstrates comprehensive expertise in clinical research and regulatory compliance, randomized controlled trials (RCTs), regulatory submissions, clinical trial dossiers, and investigational product (IP) management. His proven capabilities in scientific communications, medical affairs, and project management, combined with innovative problem-solving abilities and meticulous attention to detail, enable him to foster productive relationships across teams. Through his self-directed work ethic, he ensures the successful completion of multiple concurrent projects, whether spearheading departmental initiatives or community events, consistently delivering results within demanding timelines and demonstrating an unwavering commitment to excellence in clinical research.
Senior Data Abstractor, Cancer Registry
Sumaira Gulzar, a PhD scholar, has been an integral member of the Cancer Registry team at Shifa International Hospital since 2021. She specializes in case finding, data abstraction, and analysis of cancer-related information, which significantly contributes to our annual reports and research initiatives. Sumaira also collaborates with both internal and external stakeholders to effectively manage data requests and updates. Additionally, she plays a supportive role in research projects and clinical studies by analyzing registry data and preparing comprehensive statistical reports. Her expertise is invaluable in ensuring that we have accurate and actionable insights to enhance cancer care and research.
Clinical Research Associate
Iqra Rahim (Pharm.D) serves as a Clinical Research Associate. She holds a degree in Doctor of Pharmacy from Hamdard University, Islamabad, Pakistan. With over four years of dedicated experience in clinical research, she has contributed extensively to treatment and vaccine trials, including the CanSino and Livzon COVID-19 vaccine studies, the ACTIV-2d COVID-19 treatment trial, as well as oncology and cardiovascular studies such as Perjeta and ASPIRE-AF.
She demonstrates comprehensive expertise in trial initiation, participant screening and randomization, investigational product (IP) management, clinical documentation, and regulatory compliance, consistently adhering to Good Clinical Practice (GCP) and protocol requirements.
With a strong commitment to advancing clinical research, Iqra Rahim combines precision, professionalism, and teamwork to drive high-quality outcomes across diverse research projects.
Clinical Research Coordinator
Abdul Mannan Kiani currently serves as a Clinical Research Coordinator. He holds a Master of Science degree in Biochemistry, Molecular Biology, and Cancer Biology. Additionally, he manages the research laboratory at Shifa International Hospitals. Mr. Kiani has obtained a range of specialized certifications pertinent to clinical research, including certifications from the International Air Transport Association (IATA) for biohazardous material handling and shipment, Good Clinical Practice (GCP), Introduction to Practices and Principles of Clinical Research (IPPCR), Good Clinical Laboratory Practice (GCLP), and Research Ethics, with training provided by NIH-USA and Mayo Clinic USA. He has extensive experience in the management and coordination of clinical trials, including participation in multiple multicenter Phase III and Phase IV international studies. Mr. Kiani also possesses strong skills in manuscript development and academic publishing.
Finance Coordinator
Muhammad Asim holds an MBA in Finance and serves as a Finance Coordinator at a Clinical Research Center. He supports financial operations related to clinical research activities and ensures accurate financial reporting. With a strong foundation in finance and compliance, he contributes to efficient and reliable financial management. His work supports the organization’s operational and research goals.
Data Abstractor, Cancer Registry
Taimoor Akhter is working as Data Abstractor; he is an MPhil Scholar in Biotechnology from AAUR with a distinction in Molecular Biology. Currently working in Cancer Registry in case Finding, Data Collection and Abstraction. Mr. Akhter have also Worked as Research Associate in Aga khan University (AKU) Karachi for five years and worked as a junior scientist at NIH Islamabad. Obtained a range of specialized certifications pertinent to clinical research, including the International Air Transport Association (IATA) for biohazard materials handling and shipment and Good Clinical Laboratory Practice (GCLP) and Introduction to Principles and Practices in Clinical Research (IPPCR).
Office Assistant
Muhammad Irfan has a BA (associate degree) and is currently working as an office assistant. He maintains and keeps records of necessary documents and performs other general office duties and errands. He assists in maintenance activities, including internal networking maintenance in coordination with MIS. He also participates in quality improvement and assurance activities.
