Takhassusi Bio-Medical Contract Research Organization

Takhassusi BioMedical – CRO

With You Every Step of the Way in Advancing Clinical Research and Healthcare Solutions

At Takhassusi Bio-Medical – Contract Research Organization, we are redefining the future of clinical research through scientific excellence, advanced technologies, and strict regulatory compliance. As a licensed and full-service CRO, we support research sponsors at every stage of the clinical trial lifecycle — from protocol development and patient enrollment to data management, pharmacovigilance, and the preparation and submission of regulatory documents to the appropriate authorities, including the Saudi Food and Drug Authority (SFDA).

We are built on long-term strategic partnerships and a solid institutional foundation, enabling us to accelerate healthcare innovation and set new regional benchmarks in clinical trial quality and operational efficiency.

Rooted in over 50 years of heritage at King Faisal Specialist Hospital & Research Centre — in healthcare, research, and education — we leverage robust clinical infrastructure, strict regulatory standards, and specialized expertise to deliver reliable, high-impact research outcomes.

SFDA License Number: CT-2024-DR-0005

Vision

Takhassusi BioMedical – CRO aspires to be a pioneering leader in the Contract Research Organization (CRO) industry. We are committed to setting new benchmarks, driving innovation, and raising global healthcare standards by delivering world-class, science-driven solutions that accelerate clinical research, ensure trial success, and contribute to meaningful scientific progress.

Mission

Our mission is to redefine the future of clinical research and catalyze transformation across the pharmaceutical and healthcare sectors. Through exceptional, precision-driven CRO services, we empower local and international sponsors to lead breakthrough clinical trials, promote scientific discovery, and elevate the standard of patient care worldwide.

Study Start-Up Services

Preparing the foundation for a successful clinical trial by ensuring readiness, approvals, and strategic planning.

Protocol Design & Development

Designing scientifically valid, regulatory-compliant study protocols tailored to the research objectives.

Feasibility Study & Selection

Identifying clinical trial sites and investigators based on capability, patient access, and performance.

Regulatory & Ethics Submissions

Preparing and submitting documentation for approvals from regulatory authorities and ethics committees (IRBs).

Contract & Budget Negotiation

Managing site agreements and negotiating trial budgets with investigators and vendors.

Clinical Trial Training

Training clinical site staff, investigators, and other personnel in Good Clinical Practice (GCP) and study-specific protocols.

Site Activation & Initiation Visits

Coordinating the setup and formal launch of clinical trial sites to ensure readiness.

Clinical Trial Management

Overseeing trial activities to ensure progress, adherence to protocols, and achievement of key milestones.

Patient Recruitment & Retention

Implementing targeted strategies to recruit and retain suitable trial participants, develop and review clear and legally compliant informed consent documents for trial participants and "Provide Arabic translation".

Project Management & Budget Oversight

Services to ensure trials are completed on time, within budget, and meet all regulatory requirements. Including providing external clinical research coordinators when needed.

Risk Assessment & Mitigation

Evaluating clinical trial risks (e.g., data quality, patient safety) and designing monitoring strategies focusing on critical data and processes.

Clinical Monitoring

Verifying data accuracy, patient safety, and protocol compliance throughout the study lifecycle.

Site Monitoring Visits

Conducting initiation, interim, and close-out visits to ensure compliance with GCP, protocol, and regulatory standards. Includes source data review and informed consent verification and site performance assessment.

Safety Monitoring & Pharmacovigilance

Monitor adverse events (AE) and serious adverse events (SAE) reports to ensure participant safety and regulatory compliance. Ensure pharmacovigilance compliance.

Continuous Clinical Trial Oversight & Support

Provide ongoing monitoring across the trial lifecycle, including protocol compliance checks, issue resolution, deviation documentation, and monitoring report preparation. Collaborate closely with site staff to address operational challenges.

Data Management & Biostatistics

Ensuring high-quality clinical data through structured collection, validation, and expert analysis.

Electronic Data Capture (EDC) Setup & Management

Configuring and maintaining EDC systems to enable accurate, real-time clinical data collection.

Data Quality Assurance & Validation

Ensuring dataset accuracy by identifying and resolving inconsistencies, errors, and missing entries.

Statistical Analysis Plan (SAP) Development & Implementation

Designing detailed statistical analysis plans and ensuring their accurate execution throughout the study.

Ongoing Data Reviews & Interim Analysis

Conducting periodic data checks/reviews and generating interim analyses to support trial progress and decision-making.

Statistical Analysis & CSR Generation

Applying advanced statistical methods to analyze clinical data, and preparing detailed Clinical Study Reports (CSRs) that summarize study findings, data interpretation, and conclusions for regulatory submissions and publications.

Data and Safety Monitoring Board (DSMB) Support

Providing essential support for DSMBs by preparing interim data, coordinating meetings, and ensuring adherence to safety and ethical standards throughout the trial.

Medical Affairs

Delivering expert insights and scientific leadership to guide clinical development and therapeutic strategies.

Medical Consulting

Offering expertise on therapeutic areas, treatment landscapes, and clinical practices to guide clinical development.

Key Opinion Leaders (KOL) Engagement

Identifying and engaging with KOLs to gather insights and provide thought leadership.

Specialized Therapeutic Expertise

Offering tailored expertise in specific therapeutic areas (e.g., oncology, rare diseases, and neurology).

Regulatory Affairs Support

Ensuring alignment with regulatory authorities and global compliance standards.

Regulatory Strategy Development & Implementation

Offering expert guidance on navigating regulatory pathways for drug and device clinical trial approvals, ensuring alignment with SFDA requirements and other relevant regulatory bodies.

Regulatory Submissions & Documentation Compliance

Preparing and submitting comprehensive regulatory documents, including IND applications, investigator brochures, ethics committee and IRB submissions.

Liaison with Regulatory Bodies

Acting as a key intermediary between clients and regulatory agencies, facilitating clear and efficient communication, addressing concerns, and ensuring regulatory requirements are met promptly and accurately.

Technology & eClinical Solutions

Digitally empowering trials through integrated platforms and remote capabilities.

Clinical Trial Management Systems (CTMS)

Centralized platforms to track trial milestones, budgets, documentation, and real-time trial performance.

Randomization & Trial Supply Management (RTSM)

Managing subject randomization and inventory distribution across study sites to ensure seamless trial progression.

Telemedicine, Decentralized Trials & e-Education

Facilitating virtual participation and remote trial activities, along with providing web-based training and e-learning modules to ensure compliance and equip participants and trial staff with essential knowledge.

Additional Clinical & Research Services

Enhancing trial success with integrated laboratory, logistics, real-world data, and outcomes research solutions.

Central Bioanalytical and Laboratory Services

Offering standardized and reliable laboratory testing and biomarker analysis to ensure consistent and accurate results across clinical trial sites.

Global Logistics & Supply Chain Management

Efficiently managing the logistics of clinical trial supplies, including investigational products, lab kits, and biological samples, while maintaining regulatory compliance and temperature control for sensitive materials.

Real-World Data (RWD) and Real-World Evidence (RWE) Studies

Collecting and analyzing data from real-world clinical settings to evaluate the effectiveness and safety of treatments, supporting regulatory submissions and market access.

Health Economics & Outcomes Research

Conducting research that evaluates the clinical, economic, and patient-reported outcomes of medical treatments, assisting in value assessment, reimbursement, and improving patient care strategies.

Why Choose Us

What Makes Us a Trusted CRO Partner ?

Why Choose Takhassusi Bio-Medical – Contract Research Organization? We offer more than just clinical trial services — we are your strategic partner in delivering accurate, efficient, and regulatory-compliant research.

What sets us apart:

✔️ Deep regulatory expertise and strong alignment with local and international authorities, including the SFDA
✔️ Full-service support across all phases of the clinical trial lifecycle
✔️ Robust digital infrastructure and secure data management systems
✔️ A multidisciplinary team committed to quality, compliance, and patient safety
✔️ Accelerated timelines without compromising scientific rigor
✔️ A results-driven approach that creates real-world value for science and healthcare

We don’t just run trials — we deliver impact where it matters most.

Our Clients

Trusted by leading organizations