Director’s Message
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.
Our Team
Clinical Trial Process at SCRC
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
Our Clinical Research Trials
| 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 |
Our Partners
Why Choose SCRC?
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.
Cancer Registry
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.
Workflow
Data Collection & Standards
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.
