Clinical Data Services (Biometrics)

Clinical Data Research Services in Bangalore India

Syncorp Health CDM team has experience in handling projects in a large number of therapeutic areas. The Group has implemented CDISC standards and all processes are compliant with ICH guidelines.

Our Capabilities are as follows:

  • We provide both EDC and Paper Trial Set-Up & Management
  • We use the latest technology and processes that best meets the needs of the clients to ensure consistency and quality of the clinical trial data
  • CRF Annotation and Review
  • Data Management Plan (DMP) Development
  • Database Design
  • Edit Checks Programming
  • Data Validation Specifications
  • Data Receipt, Logging, and Tracking
  • Data Entry
  • Query Management
  • Clinical Data Coding
  • Data Quality Assurance
  • Data Transfer
  • SAE Reconciliation
  • Data Management Reporting
  • Data Review Meeting
  • Electronic Data Transfer
  • Electronic Data Capture (EDC)

Our Capabilities are as follow:

  • Descriptive statistics
  • Sample size estimation and justification
  • Statistical methods for protocol development
  • Randomization schedule generation and management
  • Statistical Analysis Plan development for individual studies
  • Programming of Statistical Tables, Listings and Graphs
  • Analysis dataset creation
  • Interim and final analyses/Support DSMB or DSRB
  • Independent QC programming
  • Support for marketing
  • Exploratory and trend analysis
  • Analyses for manuscript preparation
  • Patient Profiling
  • Patient Narratives

Medical Writing at Syncorp Health includes Regulatory, Marketing, Clinical writing services including publications. The team has expertise in developing documents in accordance to the SOPs and customized per sponsor’s requirements that comply to ICH GCP guidelines.

Our Medical writing services includes the following:

  • Investigators Brochure Update
  • Protocol Design and Development
  • Informed Consent Forms
  • Clinical Study Report (CSR) Preparations
  • Clinical Evaluation Report (CER) Preparations
  • Patients Information Leaflets
  • Regulatory Dossier Preparation
  • Regulatory writing for different therapeutic area’s

Other Writing Capabilities includes:

  • Medical and Scientific writing activities pertaining to academic
  • Medico marketing
  • Content developments
  • Digitization of niche skill medical education
  • Academicians and healthcare professionals’ publications
  • Marketing Material such as Manuscript writing, abstract preparation, case study writing, poster preparation, writing of review articles, newsletter
  • Designing of promotional materials like product monograph, presentation slides and visual aids etc
  • News
  • Alliances
  • Client Testimonials
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