What We Do?

Dimension Research operated through our clients or our own Standard Operating Procedures (SOP) that comply with industry standards and international regulatory guidelines including: ICH-GCP guidelines as well as local regulations.

Our SOPs run all the operations of clinical trials and undergo routine review process to keep them abreast with changing international or national guidelines as well as sponsor’s requirements.

  • Protocol

  • ICD

  • CRF

  • Translations

  • Paper writing

  • Statistical Plan preparation

  • Study documents preparation

  • Independent Ethics Committee

  • Regulatory Approval (Pakistan, Bangladesh and CIS)

  • Database designing

  • Data-feeding

  • Site Assessment

  • Site Selection

  • Site Training (Protocol, ICH-GCP)

  • Site Management Services

  • CTM import and management

  • Monitoring

  • Quality Assurance Audit

  • Data feeding

  • Data cleaning

  • Clinical Investigator Site Audits

  • Sponsor Audits

  • Database and Data Management audits

  • IRB Audits

  • SOP Development

  • Pre Audit Preparation

  • Preparation of  Quality Plan System  and QA Gap Analysis

Compliance & QMS   (through our US collaborative partners)

  • GMP / PAI / Mock
  • Plant Approval for FDA (USA), MHRA (UK) and TGA (Australia)

Development of Quality Management System

  • Document Management and Controls
  • Management of Investigations
  • Change Control System
  • Data Management Consulting
  • Database Design
  • Data Validation Specifications
  • Data Receipt, Logging, and Tracking
  • Data Entry
  • Query Generation, Updating, and Tracking
  • Data Quality Assurance
  • Data Transfer
  • Prepare statistical plan of clinical protocols
  • Describe both interim and final analysis strategies
  • Report Preparation
  • Prepare integrated clinical/statistical reports
  • Design tables and graphics

(Pakistan, Afghanistan, Bangladesh, Middle East, Africa and CIS countries)

  • Clinical Trials
  • Drug Registration for marketing
  • Molecule/Product Search
  • Licensing-In and Out Support

    Regulatory Affairs

  • Preparation of Regulatory Documents
  • NDA, IND, etc. and International Dossier

 

 TRAINING PROGRAMS AT DIMENSION RESEARCH CRO

EXPANSIONS TO OTHER INSTITUTES

Training programs on clinical research are run as routine calendar.

We also conduct our sessions on request by corporate (company nominated participants) or institutional batches (students off their classes/holidays/vacations) with their proposed schedules.

Earlier DR was providing services at Dow University of Health Sciences, but now other academia/institutes have joint ventures with Dimension Research for multiple short and long courses.

Dimension Research is now providing training programs in following institutes:

             1. Dadabhoy Institute of Higher Education (DIHE)

             2. Liaquat University of Medical & health Sciences (LUMHS), Jamshoro

Near Future following institutes will be also partnered for mentioned training programs:

             3. University of Punjab, Lahore