Dimension Research – 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.

Clinical Trial Services:

  • 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
  • Data Management Consulting
  • Case Report Form Design paper based and e-CRF
  • 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
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

Regulatory Affairs

  • Preparation of Regulatory Documents
  • NDA, IND, etc. and International Dossier
Our team members are the pioneers in providing certified short and long courses in ICH-GCP guidelines as well as Biostatistics and other research linked soft skills Our personnel are coordinating Dow University of Health Sciences Clinical Research Professional Certified Program More than 400 medical professionals have been trained by our team in short courses and more than 200 in long courses Out team members also assisted ministry of health in their ICH-GCP training programs.

 

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