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
San Marcos, California, United States
Products
Database Build
Services covering efficient CRF design to expeditious database lock, employing industry best practices to open, manage, and close high-quality databases.
Database Build & Maintenance
Comprehensive clinical trial database build, maintenance, and closeout services utilizing Medidata Rave and Medrio platforms.
Clinical Trial Data Management Rescue
Services to unravel and manage complex challenges in clinical trials, transitioning or optimizing data management functions to get studies back on track.
User Administration
User administration services to control and manage user access to clinical data management technology, establishing user access, role-based permissions, and on-boarding/off-boarding users for clinical trials.
End-to-end data management & IT services
End-to-end data management and IT services for clinical trials across all phases and therapeutic areas, including database build, maintenance, and closeout.
Vendor Qualifications and Audits
Comprehensive auditing services for IT vendors, data centers, and software companies to ensure regulatory compliance and assist organizations in making quality decisions about services, products, and providers.
Database Build
Services covering efficient CRF design to expeditious database lock, employing industry best practices to open, manage, and close high-quality databases.
Database Build & Maintenance
Comprehensive clinical trial database build, maintenance, and closeout services utilizing Medidata Rave and Medrio platforms.
Clinical Trial Data Management Rescue
Services to unravel and manage complex challenges in clinical trials, transitioning or optimizing data management functions to get studies back on track.
User Administration
User administration services to control and manage user access to clinical data management technology, establishing user access, role-based permissions, and on-boarding/off-boarding users for clinical trials.
End-to-end data management & IT services
End-to-end data management and IT services for clinical trials across all phases and therapeutic areas, including database build, maintenance, and closeout.
Vendor Qualifications and Audits
Comprehensive auditing services for IT vendors, data centers, and software companies to ensure regulatory compliance and assist organizations in making quality decisions about services, products, and providers.
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.