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Our Services 

 

 

 

What we do

How Can We Help You?

Medical Affairs & Medical Writing

Elevating scientific communication with precision and expertise.

  • Literature and systematic review
  • Create study design and study outline
  • Protocol design, writing, review and evaluation
  • Develop informed consent
  • Develop interim and final clinical study report
  • Create safety reports
  • Manuscript development & review
  • Clinical evaluation report writing
  • Advisory board support & report development
  • SWOT analysis report & manuscript development
  • Consensus design, questionnaire development, questionnaire coding, moderation & manuscript writing
  • Guidelines development
  • Publications support
  • Prepare medical presentations
  • Investigator brochure & promotional material development
  • Hyperlink and crosslink service
  • Develop research proposals

Biometrics

Clinical Data Management

Seamlessly managing data to drive efficient and accurate clinical trials

    • Case report form & Electronic case report form design
    • EDC selection & Database design and support
    • Edit checks development and implementation
    • Data management plan
    • Data validation plan
    • Self-evidence correction
    • Data handling and validation
    • Query management & Data cleaning
    • Medical coding
    • Quality control check

 Biostatistics

Unlocking insights and ensuring statistical rigor for informed decisions.

    • Pharmacokinetics, pharmacodynamics analysis
    • Sample size calculation and study power
    • Statistical analysis plan
    • Statistical analysis report
    • Data presentations
    • Randomization

Clinical Research Support

 Navigating the complexities of clinical trials with comprehensive project management.

  • Clinical trial project management
  • Study specific training
  • Trial master file (TMF) Management
  • Budget management
  • Regulatory audit / inspection readiness
  • CRO oversight

Consultancy

 We provide a full consultancy service to our clients, that Includes;

  • SOPs development
  • Build system, structure and capacity
  • Implement strategy and process
  • Audit preparation support

Trainings

 Empowering professionals with essential skills for clinical research excellence.

  • GCP training
  • Introduction to clinical trial and study design
  • Clinical trial conduction
  • Medical writing (Protocol design & development, Clinical study report, Manuscript, etc.)
  • Statistical analysis
  • Data Management
  • Database training
  • Quality Assurance
  • On-job training including pharmacovigilance
  • Investigators training
  • Medical team training

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