DATA MANAGEMENT

Chiltern has the resources and experience to be flexible with data collection methods, offering traditional paper CRF and eCRF services for both stand-alone data management projects and full service clinical programs. Our database programmers design databases to specifications including CDISC/CDASH, to meet specific statistical and regulatory requirements and those of all our sponsors.

A Lead Data Manager is the sponsor’s single point of contact for all data management study issues including study data management plan, coding, status reports, metrics, and any other related issues.

Chiltern’s flexible resource model allows use of a global pool of data management staff.

ELECTRONIC DATA CAPTURE: SYSTEMS

Some sponsors and investigators require a CRO partner to work within their EDC strategy, while other sponsors prefer EDC collaboration and advice. To meet this range of requirements, Chiltern has partnered with two of the leading EDC vendors while maintaining the ability to work with other systems as required:

• Datalabs® EDC/CDMS: Chiltern can perform all EDC and hybrid paper/EDC services relating to this software (program eCRFs, EDC training, data management, hosting and help desk). This results in efficiencies for our sponsors.
  
  
• Medidata Rave®: Chiltern has achieved Medidata Rave® Plus certification using Medidata’s ASPire to Win Program and has the capability to program eCRFs using Rave®, provide EDC training and data management, collaborating with Medidata for hosting and help desk.
  
  
• Chiltern has a strong track record with Phase Forward’s InForm™ software for data management and EDC training services.
  
  
• Chiltern also has experience with other EDC vendors and with sponsor’s own systems.

ELECTRONIC DATA CAPTURE: SERVICES

Chiltern consultancy services focus on supporting the implementation and management of EDC in clinical trials. This aids the relationship between the sponsor and their investigator sites through improving sites’ EDC experience and focuses on successful start-up and appropriate training.

Chiltern specialist staff have a long track record in providing training in most major EDC systems.

For studies conducted using DataLabs® EDC/CDMS software, Chiltern eCRF hosting services are available with full server redundancy.

STATISTICS

The Chiltern statistician is an integral part of your project team and is involved in all key stages of your clinical trial. We provide full service statistical support including study design, statistical methodology and analysis planning, randomization, interim analysis and data monitoring committee support, generation of high quality statistical results and outputs, interpretation of findings, and regulatory and advisory meeting support. All deliverables are reviewed and verified to ensure the highest quality prior to issue and are structured to meet the varying needs of our sponsors. SAS is used for reporting and analysis and WinNonlin for pharmacokinetic parameter estimation. Our extensive experience includes most therapeutic areas and all clinical phases.

MEDICAL WRITING

Using our experience from all clinical phases and a wide variety of therapeutic areas, Chiltern Medical Writing staff work closely with their statistical and clinical colleagues to write protocols, Clinical Study Reports (CSRs) and publications. Prior to issue, stringent QC and proofreading procedures are applied to ensure the highest quality deliverables ready for sponsor review. Chiltern has experience using sponsor CSR templates and we have our own CSR template (compliant with eCTD guidelines) should sponsors prefer. CSRs can be provided as hyperlinked and bookmarked PDF on request. Chiltern has experience with ICH E3, E6, E9, ICH M2, and eCTD guidelines.