What We Do
Instem offers both products and services to biometric and transparency leaders, helping clients clearly understand the technology options available for interconnecting manual and disparate systems and processes. Designed to be tailored to meet individual client needs, our solutions follow best practices GxP principles to ensure efficiency, quality and compliance. The strategies, solutions and services planned, built and managed by Instem provide clients a strong partner in clinical product development and sharing.
Rooted in extensive domain knowledge of SAS software, R, R&D cloud micro-services, clinical development, submission data standards such as CDISC, SDTM, AdaM, XPORT, Instem Acceleration Strategy and Acceleration Services provide enterprise level IT solutions to life science clinical trial and data science teams, including:
- Cloud enablement
- Open source adoption
- Data migration & data lakes
- Solution build, implementation, integration and adoption
- Clinical systems, business processes and talent optimization
In transparency our consultants and software engineers provide Transparency Strategy, De-Identification Services and Blur software to anonymize clinical study data and clinical study reports (CSR) for high utility sharing required by regulatory authorities. In addition to anonymization services and software we provide sponsors:
- Regulatory consulting & quantifiable risk assessments
- S.O.P. development & disclosure simulation
- Disclosure defense
Partnering with our domain experts and collaborative sponsors, Instem technologists and engineers developed Accel, a turnkey validated cloud environment for clinical trial biostatistics. These partnerships also advance development within Aspire & Blur.