RWE Clinical Study

Advancing Biomedical Research Through Excellence

Expert clinical trial management, regulatory compliance, and bioanalytical services for pharmaceutical and biotechnology companies worldwide.

our services

500+

Clinical Trials Completed

15+

Years of Excellence

98%

Regulatory Approval Rate

Our Core Services

Comprehensive solutions for biotech and pharmaceutical research needs

Clinical Trial Management

Comprehensive oversight of clinical studies from design through execution, ensuring compliance with regulatory standards.

Regulatory Affairs

Expert guidance through FDA, EMA, and global regulatory pathways for successful product approvals.

Bioanalytical Services

Advanced laboratory analysis and method development for pharmacokinetic and pharmacodynamic studies.

Data Management

Robust data collection, validation, and statistical analysis systems for clinical research.

Quality Assurance

Comprehensive quality management systems adhering to GCP, GLP, and ISO standards.

Medical Writing

Professional preparation of regulatory documents, protocols, and scientific publications.

Our Proven Methodology

A systematic approach ensuring quality, compliance, and successful outcomes

Study Design & Protocol

Study synopsis development, Clinical Study Plan (CSP), Regulatory documentation

Site Management

Site selection and feasibility, Regulatory approvals, Investigator agreements

Data Collection

Electronic Data Capture (EDC), Data validation and cleaning, Quality control procedures

Analysis & Reporting

Statistical Analysis Plan (SAP), Biostatistical analysis, Clinical Study Report (CSR)

Regulatory Compliance

All our processes adhere to international standards including ICH-GCP, FDA 21 CFR Part 11, EMA guidelines, and ISO 9001:2015 quality management systems.

Success Stories

Real-world evidence of our expertise in delivering successful clinical outcomes

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Project Deliverables

Comprehensive documentation and reporting throughout the study lifecycle

Project Phase	Deliverables
Study Design	• Study synopsis • Clinical Study Plan (CSP) • Informed Consent Form (ICF)
Site Management	• Site feasibility assessment • Regulatory submission documents • Investigator Site File (ISF)
Data Collection	• Electronic Case Report Forms (eCRF) • Data validation reports • Safety monitoring reports
Analysis	• Statistical Analysis Plan (SAP) • Statistical analysis report • Data tables and listings
Reporting	• Clinical Study Report (CSR) • Regulatory submission documents • Publication manuscripts

Quality Assurance: All deliverables undergo rigorous quality control procedures and are compliant with ICH-GCP, FDA regulations, and EMA guidelines. Documentation is maintained in accordance with 21 CFR Part 11 for electronic records.

Global Regulatory Compliance

Expert navigation through complex regulatory landscapes worldwide

United States (FDA)

FDA 21 CFR Part 11, ICH-GCP, IND/NDA submissions

European Union (EMA)

EMA guidelines, GDPR compliance, MDR/IVDR requirements

Global Markets

PMDA (Japan), NMPA (China), TGA (Australia), Health Canada

Quality Management

ISO 9001:2015 certified QMS ensuring consistent delivery of high-quality services.

Data Protection

GDPR-compliant data handling with certified Health Data Server (HDS) infrastructure for secure data storage.

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