Clinical Data Management & Biostatistics

BIOMETRIC SERVICES
     CDM tool: At MTR, data management runs on internationally approved and validated CDMS, SAS Pheedit 3.0 which undergoes exhaustive quality control testing and quality assurance oversight from CRF design through database lock.

CDM Setup

• A robust IT infrastructure is in place to ensure complete accountability of the data being processed with validated 24 × 7 physical and data security.
• Data hosting with 24x7 physical security, redundant power and internet connectivity.
• Dedicated IT and Data Base Administrator (DBA) support.
• Data backup and Disaster recovery.
• Data Analysis using SAS 9.1.3
• Business Object (Crystal reports) 11.0 for CDM reporting
• WinNonlin ,Kinetica for Pharmacokinetic Analysis
• MedDRA and WHODD dictionaries for Medical coding

Our CDM services include
• Protocol design and review
• Case Report Form (CRF) design, review and production.
• Database design
• Data entry
• Data validation and verification
• Medical review.
  
• Medical term coding.
• Lab Data transformation from non-central Laboratories.
• Quality management procedures

Our biostatistics services include
• Design, Randomization, Sample size calculation
• Data manipulation
• Statistical Analysis
• Periodic data monitoring and safety reviews (DSMB)
• Unscheduled interim analyses
• Post-hoc and exploratory analyses
• Formal interim and final analyses
• Statistical consulting
  

PHARMACOVIGILENCE

Patient safety is the fundamental principle for MTR, ahead of commercial or other interests. We conduct our clinical trials according to high standards of ethics and safety,
and we are committed to transparency on the benefits and risks of all our medicines in all communications with patients, prescribers, payers and regulators.

  MTR is committed to continuously evaluating the benefit/risk profile of our medicines. We are leaders in the field of signal detection (identifiying possible side effects associated
with our medicines) and evaluation methodology including the use of computerized systems.

 

We provide a comprehensive plan to help you manage your pre- and post-marketed product safety program. Our services include: 

 

SAE/AE Handling

• Adverse event (AE) and serious    adverse event (SAE) data entry   and  logging
• Current treatment utilization patterns
• Disease burden and prevalence

Data Management

• AE and SAE logging, tracking, coding and case processing
• MedDRA and WHO-DD coding

Medical Analysis

• AE and SAE evaluations
• SAE narrative writing
• Physician medical review and signal detection
• Literature reviews and summaries

Regulatory Reporting

• Generation of MedWatch 3500A/CIOMS I forms
• Preparation of periodic safety update reports (PSURs) and  periodic adverse   
• Drug experience reports (PADERs)
• Prompt notification of potential expedited IND, alert, and suspected
• Unexpected serious adverse reaction (SUSAR) reports