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
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