Study Conduct

EDETEK provides comprehensive business and technical solutions to advance the science of medicine and improve the quality of life of people around the world.

Data Insight

Clinical databases can be configured to be industry compliant from the start eliminating most of the need for later standardization. Legacy and non-compliant ongoing studies can be mapped and integrated with other studies which increase insight into product safety and efficacy.

Data Standardization

Legacy data to SDTM conversion including ISS/ISE integration; Mapping specification for ADaM per SAP; Reporting Table, Listing, Figure (TLF) Development; Submission document preparation eCTD

Study Conduct​

CONFORM™ CONFIGURATION

  • CRF Design & Database Setup
  • IWRS and CTMS Setup
  • Randomization Schedule
  • EDC Start Up, Training and UAT Support
  • Fast Protocol Amendment Support

DATA MANAGEMENT

  • Data Management Plan (DMP)
  • Query Management
  • Randomization and Trial Supply Management
  • External data loading and reconciliation
  • Adverse Event Reporting/Reconciliation
  • MedDRA and WHO-Drug Coding
  • Database Lock

BIOSTATISTICS AND PROGRAMMING

  • Statistical Analysis Plan (SAP)
  • SDTM Datasets
  • ADaM Dataset Creation
  • TLF Creation
  • ISS/ISE, Interim Analysis, Submission
  • Stats CSR Reporting

THERAPEUTIC AREAS

  • Oncology
  • Anti-inflammatory/Pain
  • Infectious Disease
  • Nephrology
  • Neurology/CNS
  • Cardiovascular
  • Gastroenterology
  • Ophthalmology
  • Allergy
  • Vaccine
  • PK/PD
  • Diabetes and metabolic disease
  • Dermatology

Data Insight​

For individual studies, EDETEK will provide support in selecting what data to collect and how it should be structured. Clinical databases can be configured to be industry compliant from the start eliminating most of the need for later standardization. Legacy and non-compliant ongoing studies can be mapped and integrated with other studies which increase insight into product safety and efficacy.

EDETEK’s process for data conversion utilizing our data standardization platform is cost-effective and timely eliminating the need to wait for an impending regulatory filing to initiate. The insight that can be obtained for looking at standardized, integrated data throughout the development process rather than only at the end can often save millions of dollars in failed or unnecessary studies. Of course, if you’ve waited until the last minute to prepare for an Agency Safety Update Report or NDA Filing, we can accommodate those needs as well. Let’s discuss how easy it can be!

If you are considering enterprise transactional tools for data standardization please visit CONFORM™ DSP.

Data Standardization

SDTM

  • Legacy data to SDTM conversion including ISS/ISE integration
  • Define and SDRG
  • SDTM data validation including conformance and content check
  • Clinical Data Repository (CDR) provisioning
 

ADAM

  • Mapping specification for ADaM per SAP
  • ADaM Generation
  • Define and SDRG
  • ADaM data validation
  • Analytical Data Mart (ADM) Provisioning
 

REPORTING

  • Table, Listing, Figure (TLF) Development
  • TLF Validation
  • Patient Profile Creation
  • Data Visualization
  • Ad-hoc Reporting
  • Medical Writing

SUBMISSION

  • Submission document preparation
  • eCTD
  • Submission readiness review
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