About Us

Who We Are

Instem is dedicated to improving the life science industry by transforming domain knowledge into results. Driven by a passion to improve wellbeing, Instem designs, builds and implements clinical and transparency solutions and provides services to client teams in R&D IT, Biostatistics and Transparency.

In clinical trials, our life science consultants and technologists optimize systems, business processes and programming talent. The clinical analytics solutions (SCEs) built in partnership with our clients provide performance and flexibility for pivotal trial and real-world data analysis.These solutions are designed to maintain validation requirements and can be deployed and managed in either the public or Instem cloud.

With the vision to transform the life sciences landscape by allowing everyone open and flexible access to data, our transparency consultants and delivery teams lead Transparency Strategy and leverage Blur to provide high utility data & documents for sharing.

Doing More. Going Further Together.

Now part of the Instem organization, we remain committed to continuing the acceleration of clinical development timelines while having an even broader impact on human health and wellbeing.

Our combined strength positions us as the foremost authority and driving force in generating, analyzing and leveraging data from Discovery through late-stage Clinical Trials. Our increased capabilities will also enable us to meet the growing demand for the creation of a more connected ecosystem across the life sciences in the global effort to bring life enhancing products to market faster.

 

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100+ Life Science Companies Trust Acceleration Strategy and Services
5000+ Managed Cloud Users Public and d-wise cloud
#1 Blur is the most used software for clinical trial anonymization
30+ Regulatory Sharing Submissions led by d-wise consultants

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.

Clinical Trial Acceleration

Accelerating clinical trials requires an automated, validated, and scalable system. Our technology and clinical trial experts have created services and products that enable you to focus on the science and get to market faster, including our cloud-based SCE Accel and our Acceleration Strategies and Services.

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Clinical Trial Transparency

Instem transparency services and software empower sponsors to meet EMA Policy 0070 and Health Canada Public Release of Clinical Information.

Built in collaboration with industry sponsors, Blur is an anonymization software that measures re-identification risk and automates anonymization of both document and data through Natural Language Programming. Available as a SaaS or as an outsourced service, Instem also provides transparency strategy, software, and resources to enable sharing that powers medical innovation.

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