We begin by working through the study protocol to define your objectives. Anticipating challenges and technology requirements at this early stage allows us to develop a truly customized approach.
Global Experience and Reach
Being based in multiples regions means we’re always able to provide timely support to investigator sites. We’ve previously executed Phase I – IV studies on a global scale in a broad range of therapeutic areas.
We offer technological expertise in running clinical trials on Electronic Data Capture (EDC), Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platforms and importing data from lab, imaging and Patient Reported Outcome (PRO) devices. We use Medidata CTMS as our primary platform for study management and tracking, and Medidata Rave® for EDC. Read about our Medidata accreditation here. Alternatively, you can click here to download a copy of our article.
Our data management services include:
- Input during protocol development Electronic Case Report Form (eCRF) design
- Database design and validation
- Electronic edit check programming and validation
- Consulting/training for implementation of new systems, coding and dictionary management
- Creation of new Standard Operating Procedures (SOPs)
- Managing outsourcing to ensure compliance with your SOPs
- With Clinical Research Associates (CRAs): risk-based monitoring and analysis
- With Medical Monitors: assessment of patient safety on an ongoing basis
- Electronic Data Capture (EDC)
- Global cleaning to all required standards: 21 Code of Federal Regulations (CFR) part 11 compliant Clinical Data Management System (CDMS), according to the International Council for Harmonization of Good Clinical Practice (ICH-GCP)
- Coding of medical terms (secondary diagnoses, medical history and adverse events) according to Medical Dictionary for Regulatory activities (MedDRA)
- Coding of medications (previous and concomitant medications) according to World Health Organization Drug Dictionary (WHODrug)
- Ongoing Quality Control (QC) of data including final QC prior to database lock
- Ongoing serious adverse event reconciliation
- Integration of third-party vendor data including Electrocardiogram (ECG) data; central and local laboratory data; imaging data; and PK data
- Transfer of data for statistical analysis and submission to the regulatory authorities, according to Clinical Data Interchange Standards Consortium (CDISC) or client specific standards
Get in touch to find out more about data management.
Clintec’s Data Management Service, combined with Biostatistics and Programming, is an extension of the Biometrics department, led by Jeanne Strain.
Jeanne Strain, Global Head, Biometrics
Jeanne has over 30 years of industry experience in Data Management and Biostatistics, with 20 years in the CRO space. Prior to this she spent 16 years at a major pharmaceutical company with the majority of her time focused on Data Management Operations as well as selection, validation, and implementation of clinical systems. Jeanne has been responsible for providing leadership for Data Management, Biostatistics, Statistical Programming, Medical Writing, Interactive Response Technology and Document Management & Publishing departments globally. Jeanne has experience in all phases of clinical trials from Phase I through IV, post-approval studies and a multitude of therapeutic areas. She has overseen operations on three continents and seven countries, including significant experience overseeing operations in Asia-Pacific, allowing for greater efficiency and cost containment. Jeanne received her BS in Biochemistry from Rutgers University and her MS in Biology with a minor in Business from Seton Hall University.