Clinical Trial Management

Data Management

Integrity of a clinical trial is based upon comprehensive and accurate database. We support our clients to develop and manage comprehensive and accurate database that also keep the Reliability of a clinical trial. Our data tracking system allow our clients to follow up on the progress of their study. We provide highest quality service. We strictly follow ICH guidelines for data management. Our Data management service may include;

  • Case Report Form Design, Printing, Distribution, Collection, and Analysis
  • Data Validation Specifications
  • Database Design
  • Data Receipt, Logging, and Tracking
  • Data Entry
  • Query Generation, Updating, and Tracking
  • Centralized Data Coding
  • Data Quality Assurance
  • Data Transfer
  • Database Access Management
  • Data Management Reporting
  • Data Review Meeting

Clinical Trial Execution

Our Clinical Trial Unit assists our clients to develop the right plan to meet their clinical research objectives. We analyze and diagnose the client's research and technical capabilities. Our Clinical Trial Unit will provide you with highly specialized consultants, coordinators and GCP (QA) Auditors to suit your request. We focus on following;

  • Ensuring the implementation of project plans.
  • Responsibility for site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and Convince Standard Operating Procedures.
  • Monitor the clinical trial progress ensuring that it is recorded, conducted and reported in accordance with relevant regulatory requirements.
  • Coordinates with Principal Investigator to help to ensure that clinical research and related activities are performed in accordance with the company’s policies and procedures.
  • Assists the PI in the development and Maintains of the documents of the study.
  • Cooperates with PI’s and monitoring efforts related to sponsored program administration and report instances of noncompliance to the appropriate.
  • Coordinates and facilitates monitoring and auditing visits.
  • Provide coordination and support for data collection and online data entry system.

Workshop for Clinical Trial according to GCP Guidelines

Our Clinical Trial Unit team is a backbone of the trainning we provide. It's through the knowledge and skills or our team that will help our clients to develop the right plan to meet their clinical research objectives. We are integeral to success of our workshop. We will provide you with the most comrehensive and Up-to-date Clinical Research Training. Our commitment is to provide you a meximum return on your investment through the quality education imparted to you by our team of experts.

  • Introduction and the principales of ICH GCP.
  • Informed Consents.
  • Ethics.
  • Investigator's Responsibility.
  • Sponsor Responsibility.
  • Clinical Trial Protocol.
  • Investigator Brochure.
  • Essential Documents.
  • Safety Reportings.