INSIGHT CLINICAL CONSULTING LIMITED
Insight Clinical Consulting is a data management and information technology consultancy dedicated to supporting emerging to mid-sized biotechnology companies in clinical trials. With a team of industry veterans, they provide high-end data management solutions, including database build, maintenance, and closeout, as well as IT support, vendor qualification, and auditing services. Their mission is to deliver high-quality, efficient, and compliant data management services to ensure successful clinical trial outcomes across all phases and therapeutic areas.
Industries
Nr. of Employees
small (1-50)
INSIGHT CLINICAL CONSULTING LIMITED
Services
Consulting support spanning database build, maintenance, review, cleaning, locking, and closeout for clinical trials across phases and therapeutic areas.
Study build services, database programming, system setup, and UAT for EDC platforms; offered as full-service or build-only to augment existing teams.
Vendor selection, qualification, re-qualification, and IT vendor audits to assess compliance and fit for clinical trial operations.
Creation and review of standard operating procedures for internal and outsourced data management to support consistent, auditable workflows.
Rapid remediation and transition of data management functions for studies that are off track, including process optimization and temporary deployment of experienced data managers.
Standardized coding of trial data (AEs, medical history, concomitant medications) using industry coding dictionaries to prepare datasets for analysis and submission.
Consulting support spanning database build, maintenance, review, cleaning, locking, and closeout for clinical trials across phases and therapeutic areas.
Study build services, database programming, system setup, and UAT for EDC platforms; offered as full-service or build-only to augment existing teams.
Vendor selection, qualification, re-qualification, and IT vendor audits to assess compliance and fit for clinical trial operations.
Creation and review of standard operating procedures for internal and outsourced data management to support consistent, auditable workflows.
Rapid remediation and transition of data management functions for studies that are off track, including process optimization and temporary deployment of experienced data managers.
Standardized coding of trial data (AEs, medical history, concomitant medications) using industry coding dictionaries to prepare datasets for analysis and submission.
Expertise Areas
- Clinical trial data management
- EDC implementation and study build
- Clinical database programming
- Medical coding and terminology management
Key Technologies
- Electronic Data Capture (EDC) platforms
- Clinical Data Management Systems (CDMS)
- CDISC / CDASH data standards
- 21 CFR Part 11 compliance practices
News & Updates
Insight Clinical Consulting has achieved accreditation for Rave EDC, joining Medidata’s partner program, enabling them to offer comprehensive Rave EDC services to sponsors.
Achieved accreditation for Rave EDC, enabling the company to offer full Rave EDC and CDM services.
Insight Clinical Consulting has achieved accreditation for Rave EDC, joining Medidata’s partner program, enabling them to offer comprehensive Rave EDC services to sponsors.
Achieved accreditation for Rave EDC, enabling the company to offer full Rave EDC and CDM services.