Clinical Trials
We provide comprehensive services for a wide range of industry- and government-funded clinical trials. Our team has expertise in study design, data management, project management, trial monitoring, statistical analyses, and regulatory compliance to ensure the success of multicenter trials.
Trial Design
Our expert biostatisticians collaborate with investigators during protocol development to:
- Identify optimal trial designs, such as adaptive designs, Bayesian designs, enrichment strategies, and cluster-randomized designs etc.
- Define study hypotheses and endpoints.
- Perform sample size and power calculations.
- Draft statistical analysis plans (SAPs).
- Serve as a liaison between WCM PIs and external trial networks and sponsors.
Data Management
We offer a full suite of data management services, ensuring high-quality and regulatory-compliant data collection and processing:
- Electronic Case Report Form (eCRF) design.
- Development of data management plans (DMPs).
- Comprehensive electronic data capture (EDC) programming: Our dedicated team builds EDC infrastructure using platforms such as REDCap, REDCap Cloud, and Clinvestigator etc.
- Implementation of data standards (CDISC, SDTM, ADaM) and validation checks.
- Quality control, audit trails, and documentation.
- Site training for EDC and data management systems.
- Medical coding for adverse events (AEs), severe AEs (SAEs) and concomitant medications.
- Full data linkage and integration, including eCRFs, imaging, laboratory data, and Electronic Health Records (EHRs).
- Assurance of regulatory compliance.
Trial Monitoring
Our team provides end-to-end clinical trial monitoring (CTM), ensuring data integrity and protocol adherence:
- Randomization scheme development and implementation (stratified, block, cluster randomization etc).
- Enrollment and follow-up tracking.
- Monitoring and reporting of safety events and protocol deviations.
- Identification and resolution of data quality issues via Source Data Verification (SDV), query management and risk-based monitoring (RBM).
- Site coordination, training, and investigator meetings.
- Preparation of Data and Safety Monitoring Board (DSMB) charters, reports, and meeting coordination.
- Execution of interim analyses to support decision-making.
Data Analysis
We execute interim and final analyses as outlined in the SAP, generating regulatory and publication-ready reports:
- Creation and validation of analysis datasets.
- Planning, analysis, and writing of manuscripts, clinical study reports (CSRs), and regulatory submissions.
- High-quality figure and table generation for publications.
- Management and execution of secondary analyses for completed trials.
Regulatory Compliance
We ensure full compliance with regulatory requirements across all stages of the clinical trial process:
- Adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines.
- Preparation for regulatory submissions, including CSRs and data packages for FDA, EMA, and other regulatory agencies.
- Management of electronic records and signatures in accordance with 21 CFR Part 11.
- Assurance of compliance with HIPAA for patient data protection.
- Validation of clinical data integrity in line with Good Clinical Data Management Practices (GCDMP).
SOPs
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Real-World Data (RWD) Analysis
Our experts in Artificial Intelligence, health informatics, and biostatistics provide study design an analytics support for large-scale RWD projects.
Data Acquisition and Integration
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Data Cleaning and Quality Control
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Data Harmonization
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Statistical Analysis
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Data Visualization and Reporting
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