Evolving a Biotech Client’s IT Strategy & Operating Model for Global Phase 1
Client identity has been withheld to protect confidentiality. References are available upon request.
From Strategic IT Review to Embedded CIO/CISO Leadership Through Phase 1
As a biotech company prepared for and entered Phase 1, Mantle was engaged to independently assess its IT operating model and define a phase-appropriate path forward. Mantle quickly evolved into an embedded fractional CIO and CISO advisor, providing technology and security leadership while working with legal counsel and company leadership to address GDPR requirements in Europe and PIPL-related data privacy considerations arising from clinical activity in China.
Embedded technology leadership for a biotechnology company transitioning from Preclinical to Phase 1.
The client needed an independent assessment of its IT function and operating model to identify what needed to evolve as the company entered its next stage of growth—and to establish a practical roadmap through Phase 2 and other key business and clinical-development inflection points.
The client engaged Mantle to independently assess its IT function, operating model, and existing service-provider structure. Leadership wanted a clear view of what was working, where the model needed to change, and how IT should evolve to better support the business going forward.
Mantle evaluated the current environment and developed a pragmatic roadmap for the next stage, including recommendations around the future operating model and provider landscape. As the relationship deepened, Mantle’s role expanded beyond the initial review into embedded CIO/CISO leadership and business partnering across areas such as data privacy and clinical-data security.
From independent assessment to embedded technology leadership.
Assess the current model
Mantle began with a strategic review of the IT function, operating model, and service-provider structure to establish an independent view of the current environment.
Define the path forward
The review informed a practical roadmap for how the function should evolve, including priorities for technology, cybersecurity, operating structure, and external providers.
Embed CIO and CISO leadership
Mantle’s role expanded into ongoing fractional CIO and CISO leadership, connecting day-to-day technology decisions with broader business, security, and clinical-development priorities.
Extend governance into key risk areas
Mantle partnered with legal counsel and functional leaders on GDPR and PIPL-related privacy requirements, supporting policies and technical and organizational measures while advising on the protection of sensitive clinical-development data.
Outcomes
Clearer direction for the IT function
Supported by an independent assessment, defined roadmap, and recommendations for how the operating model and provider structure should evolve.
Embedded CIO and CISO leadership
Providing ongoing technology and security guidance as the company advanced from preclinical development into Phase 1 and beyond.
More formalized international data privacy
Policies and technical and organizational measures developed in partnership with legal counsel around GDPR and PIPL-related needs.
Structured access for sensitive clinical-development data
A more deliberate model for managing permissions and access to sensitive clinical-development data within SharePoint.
Expanded cybersecurity monitoring capabilities
Managed detection and response implemented as part of the broader security program.
