Welcome to our website! Working Hours: Mon-Sat 10:00-20:00 / info@akisthemes.com
Welcome to our website! Working Hours: Mon-Sat 10:00-20:00 / info@akisthemes.com

Clinical Trials

Statistical Consulting Services in the Area of Pre-Clinical & Clinical Services of Medical Devices Which Shall Include But Not Limited to: 

  1. Sample size calculation
  2. All kind of statistical assistance in pre/post clinical study design
  3. Justification for each statistical calculation
  4. Determination of data collection methodology
  5. Review data collection methods
  6. Support in terms of validated statistical tool usage
  7. Review of CRF/e-CRF
  8. Interim Analysis of report
  9. Statistical Analysis Plan (SAP) report
  10. Final analysis of complete report

Medical device Clinical Trial : Training & Development services

Designing Clinical research: Basic Ingredients

  1. Getting Started: The Anatomy and Physiology of Clinical Research
  2. Conceiving the Research Question and Developing the Study Plan
  3. Choosing the Study Subjects
  4. Planning the Measurements
  5. Hypothesis and underlying Principles
  6. Estimating Sample Size and Power

Designing Clinical research: Study Design

  1. Designing Cross Sectional and Cohort Studies
  2. Designing Case-Control Studies
  3. Designing Studies of Medical Tests
  4. Research Using Existing Data

Designing Clinical research: Implementation

  1. Designing Questionnaires, Interviews and Online Surveys
  2. Data Management
  3. Implementing the Study and Quality Control

Good clinical practice

  1. Introduction of ICH E-6, ICH E-6 R2, Indian GCP
  2. Role and responsibilities (Sponsor, Investigator, Ethics committee)
  3. Institutional Review Boards, institutional and independent ethics committee
  4. Informed Consent, Participant Safety & Adverse Events
  5. Research Misconduct and study Protocol
  6. Documentation & Record-Keeping