Dataplus Pharma Services, Inc.

Data Management

  • Electronic Case Report Form (eCRF)

  • Database design and consistency check programming

  • Clinical Data Management Plan and Validation Rules

  • Dictionary Services (MedDRA& WHODD)

  • SAE Reporting and Reconciliation


CDISC Implementation

  • SDTM annotated Case Report Form

  • SDTM & ADaM specifications and datasets

  • Generation of Define.XML file


Biostatistics

  • Development of study design and sample size/power calculations

  • Randomization

  • Statistical Analysis Plan (SAP)

  • Tables, Listings, and Figures

  • Statistical programming

  • Statistical reports

  • Data and Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) participation


Medical Writing

  • Clinical study protocols

  • Developmental Safety Update Reports

  • Investigator Brochures

  • Informed consent forms

  • Clinical study reports

  • Clinical study report verification

  • Case report forms


Regulatory Affairs

  • Institutional Review Board (IRB) submissions

  • Collection and maintenance of required site essential documents

  • Informed Consent Form (ICF)

  • Trial Master File (TMF) support

Functional Service Provider (FSP)

  • Specialized and skilled resources

  • Global expertise in specific functions

  • Annual performance review and reports

  • Continuous education and motivation

  • Provision of excellent team management