PHARMEXPERT CRO offers to local and international companies functional services below in the field of interventional and non-interventional study/trial.
Safety Management
- Individual Case Safety Report (ICSR) Processing (Medical Evaluation of Cases)
- Safety Database
- Serious Adverse Event (SAE) Reconciliation (Necessary for Regulatory Authorities (RA) Submission)
- Serious Adverse Event (SAE) Narratives Preparation
- Case Report Form (CRF) and line-listings safety review (To address any site concerns regarding health state of participants)
Medical Monitoring
- Provide Medical Monitoring Coverage 24/7
- Take up Data and Safety Management Board (DSMB) obligations
- Develop Safety Management Plan (SMP)
- Support Site and Study Team by providing specific medical consultations
- Provide Medical Insight on Study Documents Development
Study Management
- Project Management (from study planning to the final deliverable)
- Clinical Monitoring (patient safety, staff mentoring and data integrity monitoring)
- Site and Study Team Support (resolving any medical and trial conduct related matters)
- Essential Document Handling (for all document types)
- Site Management (collaboration with site members, clinical site preparation, procedures’ implementation)
Medical Writing
- Study Abstracts
- Clinical Protocols
- Informed Consent Forms
- Patient Information Sheets
- Case Report Form
- Clinical Study Reports
- Risk Management Plan /Risk Evaluation and Mitigation Strategy (RMP/REMS)
CRF and Database Design
- Case Report Form (CRF) Design and Development
- Case Report Form (CRF) Completion Guidelines Development
- Database Design Development
- Database Lock
- Database Archiving
Data Validation
- Clinical Data Interchange Standards Consortium (CDISC) compliant datasets and documentation (to guarantee data standardization)
- Data Management Plan Development (describing data-flow related procedures for clinical trials or other types of investigations)
- Data Validation Plan Development (manual for data control)
- Automatic and Manual Data Validation (different tools to ensure data integrity)
- Query Management (resolution tools to provide discrepancy-free data)
Medical Coding
- MedDRA Terms Coding (using the latest version of MedDRA dictionary)
- WHO Drug Terms Coding
- Coding Consistency Review (in accordance with MedDRA, WHO Drug and other specific recommendations)
Biostatistics
- Statistical Analysis Software (SAS)-Programming (customized programs with a focus on project requirements)
- Protocol Design and Sampling
- Statistical Analysis Plan
- Statistical Analysis Report
- Programming of Tables, Listings, and Figures