Clinical Data Management

Izenbio understand the clients need of consistent, high-quality data in a clinical trials process, the need to ensure regulatory compliance and controlling the costs associated with managing the clinical trial data. Izenbio brings together its best team to help you generate data that meet our rigorous standards of accuracy, accessibility, source verified as well as time and cost efficient.

To accommodate each client's project specifications, our clinical data management team can target paper-based, fax-based and EDC-based systems in all phases and platform. Our infrastructure and flexible service models fulfill cost effective requirements of a single trial or requirements for complete outsourcing of large groups of studies as Functional Service Provider (FSP).

For more information on Izenbio's Clinical Data Management Services,

Highlights

  • Platforms Offered: Oracle Clinical 4.5.3 ®, SyMetric 9.1.12
  • Data collection: Traditional Paper format (Scan/Fax/Hardcopy), Remote Data Capture – Oracle Clinical
  • Process: Robust SOPs in place, Experience working on Client's SOPs
  • Experience of more than 200 projects over 10 years

CDM Services

Data Management Services

Izenbio offers you a full range of data management services that can be combined to meet needs of virtually any proportion. We handle clinical studies from phase I-IV of all sizes, as well as stand-alone projects. Our services include:

  • Project Specific Clinical Data Management Plan
  • Customized Database Design & Development
  • Edit, Validation and Design check programming
  • Double Data Entry Comparison and Adjudication
  • Data Validation
  • Data Cleaning
  • Query Management
  • Dictionary Services (MedDra,WHODD or your own dictionary)
  • Quality Control and Data Quality Audits
  • Serious Adverse Event Reconciliation
  • Data Listings
  • Database Lock and Export to SAS
  • Delivery of Clean Data Files & Documentation Clinical Data Management Report
  • Project Data Archival and Storage

Flexible Service Models

Designed around your needs

When you work with the leader in the data management industry, you expect the experts to deploy data management tools in the way that best meets your needs and budget. That's why Izenbio is the leading CRO offering a Functional Service Provider (FSP) model.

Our FSP program offers full access to Izenbio's global resource base while maximizing consistency and cost flexibility. It is easy to customize, providing greater productivity and tailoring capacity to your needs.

Izenbio also offers a variety of other business models to precisely meet your needs:

  • Dedicated DM Group solutions use dedicated employees who work for only one sponsor. This model offers you a variety of benefits to help deal with consistently high workloads.

  • Facilities-Based Models give Izenbio responsibility for your existing data management employees and sometimes your facilities as well. We use a revenue contract to transition the work to Izenbio offices.

 

Our CDM Experience

Therapeutic Area Paper CRF or e-CRF No. of Patients FDA or EMEA Submission Country of Study
Dermatology e-CRF 1,600 FDA USA & India
Dermatology Paper CRF 30 FDA USA
Epidemiology Paper CRF 251 EMEA Thailand
Epidemiology Paper CRF 10,000 EMEA China, India, Bangladesh, Indonesia, Pakistan, Philippines, Srilanka, Thailand & Vietnam
Epidemiology Paper CRF 4,000 EMEA Turkey, Australia, Argentina & Czech Republic
Fermented Diary Products Paper CRF 19 FDA USA
Gastroenterology Paper CRF 402 FDA USA
Gynecology e-CRF 200 FDA USA & India
Gynecology Paper CRF 66 FDA USA
Gynecology Paper CRF 1,443 FDA USA
Gynecology Paper CRF 843 FDA USA
Immunology Paper CRF 408 EMEA Thailand
Immunology Paper CRF 516 EMEA Thailand
Immunology Paper CRF 100 EMEA India
Immunology Paper CRF 167 EMEA Thailand
Neurology Paper CRF 24 FDA USA
Neurology Paper CRF 24 FDA USA
Neurology e-CRF 200 FDA USA, Canada & India
Neurology Paper CRF 150 FDA USA & India
Neurology Paper CRF 24 FDA USA
Oncology Paper CRF 52 FDA USA & Canada
Ophthalmology Paper CRF 50 EMEA Russia
Orthopetic Paper CRF 12 FDA USA
Orthopetic Paper CRF 9 FDA USA
Pshychiatry e-CRF 228 FDA USA, India, Philippines, Malaysia
Cardiovascular e-CRF 3300 FDA USA

Copyright © 2014 izenbio.com. All rights reserved.