Introduction

The Massachusetts Life Sciences Center (MLSC) is a quasi-state agency committed to advancing the life sciences ecosystem in Massachusetts. MLSC seeks a vendor to serve as the central IRB for the MLSC Biobank Program, which is being launched to establish a statewide, disease-specific biobank. In the first phase, the disease areas of focus will be colorectal cancer and Alzheimer’s disease and related dementias. More than ten academic medical centers will participate in sample collection. For this endeavor, we will need a central IRB vendor managing and coordinating with all the other collection sites and institutions.

Scope of Services

The selected vendor will provide central IRB services to support the establishment and ongoing operation of the MLSC Disease-Specific Biobank. The Biobank will involve multiple academic medical centers, community hospitals, and research partners across Massachusetts. The awardee will be responsible for ensuring that all protocol reviews, amendments, and continuing reviews are conducted in compliance with federal, state, and institutional regulations.

The scope of work includes, but is not limited to, the following:

1. Central IRB Review and Oversight

· Serve as the single IRB of record for all participating sites, including academic medical centers and community health systems.

· Conduct initial review and approval of the biobank master protocol, consent forms, and associated participant materials.

· Ensure compliance with FDA regulations, the Common Rule, HIPAA, state privacy laws, and any relevant institutional requirements.

2. Multi-Site Coordination and Onboarding

· Support onboarding and reliance agreement execution with each participating institution.

· Maintain documentation of reliance agreements and communication with institutional HRPP/IRB offices.

· Provide orientation and guidance to site investigators and study staff regarding IRB processes and requirements.

3. Consent and Participant Privacy Materials

· Review and approve standardized informed consent forms, assent forms (as applicable), and privacy authorization language, short consent forms for not as common languages as needed

· Ensure that consent language meets the biobank’s requirements for broad data and sample use, including future unspecified research, re-contact, and withdrawal procedures.

· Support translation and culturally appropriate materials, as needed.

4. Protocol Amendments and Continuing Review

· Conduct timely review of all protocol amendments, updated consent documents, revised operational workflows, and any new sample or data collection elements.

· Provide annual continuing review and ongoing oversight reports.

· Maintain version control and ensure timely distribution of approved documents to all participating sites.

5. Adverse Event and Non-Compliance Reporting

· Receive, review, and track any unanticipated problems involving risk to participants, serious or non-compliance events, or other reportable issues.

· Provide direction on corrective and preventive actions as needed.

· Communicate required reports to regulatory authorities, if applicable.

· Template for CAPAs, tracking adverse events and deviations

6. Turnaround Time and Service Levels

· Meet agreed-upon turnaround times for protocol reviews, amendments, reliance agreements, and reportable events.

· Provide transparent service metrics and communication timelines.

7. Documentation, Records Management, and Audit Support

· Maintain complete regulatory documentation of all IRB decisions.

· Provide audit-ready records to the biobank operations team and regulatory agencies, if required.

· Ensure secure record storage, confidentiality, and controlled access.

· Copies of applicable documents, including the protocol, outcome letters, local context review form(s), and consent forms specific to each recruiting site

8. Systems and Communications

· Provide an electronic IRB management platform with role-based access for multiple institutions.

· Ensure user support, training, and technical assistance for site personnel.

· Maintain clear communication channels and designated points of contact for escalations  

Term

The engagement will be for a five (5) year term with options to renew

Contact

For questions regarding this RFP, contact: BioBank@masslifesciences.com

This solicitation does not constitute an obligation to fund any proposals. The MLSC reserves the right to modify or cancel this RFP at any time and may request further clarifications or conduct interviews as part of the selection process. 

Cloud Infrastructure and Managed IT Services for the Massachusetts Lifesciences Center (MLSC) Biobank Program 

 1. Background and Purpose   The MLSC Biobank Program is a multi-institutional initiative designed to support biomedical research through the secure collection, storage, processing, and management of biospecimens and associated data.   To support this effort, MLSC is soliciting proposals from qualified vendors to provide enterprise-grade cloud infrastructure and managed IT services, comparable in capability, scale, and reliability to leading hyperscale cloud service providers. The selected vendor will deliver secure, scalable cloud services and ongoing IT operational support to ensure system availability, performance, and compliance for the Biobank Program. 

 2. Scope of Work   The selected vendor will provide cloud infrastructure and managed IT services with the following capabilities:   

A. Cloud Infrastructure Services 

• Provision and management of elastic, on-demand cloud compute, storage, and networking resources 
• Scalable object, block, and archival storage suitable for large biomedical datasets 
• High availability architecture with redundancy across regions or availability zones 
• Support for development, testing, and production environments 

 B. Security and Identity Services 

• Identity and access management with role-based permissions 
• Network security controls, including firewalls and private networking – minimum AES-256 
• Encryption of data in transit and at rest using industry-standard methods – minimum TLS 1.2 
• Continuous security monitoring and logging 

 C. Managed IT and Platform Support 

• Ongoing infrastructure management, monitoring, and optimization 
• Incident detection, response, and root-cause analysis 
• Patch management and system updates – immediate notification of breach 
• Technical support for MLSC-authorized users and administrators 

 D. Disaster Recovery and Resilience 

• Automated backups and snapshot management  
• Daily backups with geo-redundant storage 
• Regular restore testing, at least annually 
• Separate environments for backup and disaster recovery 
• Disaster recovery architecture with defined recovery objectives 
• Regular testing and validation of recovery procedures 
• Business continuity planning aligned with program risk tolerance 

 E. Program Coordination and Support 

• Dedicated technical account management 
• Coordination with other Biobank vendors, including data platform and analytics providers 
• Support for onboarding new workloads, tools, or services as program needs evolve. 
• Participation in scheduled technical and operational reviews 

 3. Vendor Qualifications   Responding vendors should demonstrate: 

• Experience providing hyperscale or enterprise-grade cloud infrastructure and managed services 
• Proven support for regulated or sensitive data environments, including healthcare or research 
• Strong operational maturity and service reliability 
• Experience working with public-sector, academic, or healthcare organizations 
• Ability to support a multi-year, growing program 

 4. Proposal Requirements   Proposals must include: 

1. Company overview and relevant cloud services experience 
2. Description of proposed cloud service offerings and architecture 
3. Security, identity, and monitoring capabilities 
4. Managed services and IT support model 
5. Disaster recovery and resilience approach 
6. Implementation plan and onboarding timeline 
7. Pricing model and cost transparency 
8. References from comparable cloud infrastructure engagements 

 5. Evaluation Criteria   Proposals will be evaluated based on: 

• Alignment with program requirements and scale 
• Breadth and maturity of cloud service offerings 
• Security, reliability, and compliance posture 
• Quality of managed services and support 
• Cost structure and long-term sustainability 

 6. Anticipated Timeline 

• RFP release: 1.26.26 
• Proposal submission deadline: 2.27.26 

 7. Submission Instructions 

Proposals should be submitted electronically via Submittable. Selected proposals may be invited to interview. 

 8. Term 

The engagement will be for a five (5) year term with options to renew       

9. Contact 

For questions regarding this RFP, contact: BioBank@masslifesciences.com   

This solicitation does not constitute an obligation to fund any proposals. The MLSC reserves the right to modify or cancel this RFP at any time and may request further clarifications or conduct interviews as part of the selection process.       

Appendix:

 Security, Privacy, and Compliance Requirements Security 

• HIPAA-aligned cloud services and controls 
• Encryption in transit and at rest 
• Identity and access management 
• Continuous monitoring and logging 

 Compliance and Standards 

• SOC 2 Type II or equivalent 
• ISO 27001 or equivalent 
• Transparent disclosure of subcontractors and underlying infrastructure providers 

 Business Continuity 

• Multi-region or equivalent redundancy 
• Automated backups and disaster recovery 
• Defined service-level commitments 

Centralized Data Storage, Curation, and Access Platform for the Biobank Program 

 1. Background and Purpose   The MLSC Biobank Program is a multi-institutional initiative designed to support biomedical research through the centralized management of biospecimen-associated clinical, molecular, and longitudinal data. The program seeks to enable secure data ingestion, harmonization, long-term stewardship, and governed access to support discovery, translational research, and clinical innovation. The Biobank Program is soliciting proposals from qualified vendors to provide a secure, scalable, and compliant data storage and curation platform that will serve as the central data infrastructure for the program. 

 2. Scope of Work   The selected vendor will be responsible for providing and maintaining an end-to-end data platform with the following capabilities.  

A. Data Ingestion and Integration 

• Secure ingestion of multi-modal data, including clinical, demographic, pathology, imaging, laboratory, molecular, and longitudinal data. 
• Support for data submissions from multiple contributing institutions using standardized formats. 
• Validation, quality control, and error reporting at data intake. 

 B. Data Storage and Infrastructure 

• Cloud-based or hybrid infrastructure capable of scaling with program growth. 
• Secure storage architecture with redundancy, backup, and disaster recovery. 
• Persistent identifiers and traceability linking datasets to biospecimens without direct identifiers. 
• Logical separation of datasets by project or access tier as required. 

 C. Data Curation and Harmonization 

• Data cleaning, normalization, and harmonization across sites and data types. 
• Support for standard ontologies, controlled vocabularies, and metadata schemas where applicable. 
• Maintenance of data dictionaries, provenance records, and version history. 
• Ongoing curation as new data are generated or updated. 

 D. Data Governance and Access Enablement 

• Tools to support controlled data access workflows aligned with program policies. 
• Role-based access control, audit logs, and usage monitoring. 
• Ability to enforce data use limitations, consent-based restrictions, and withdrawal requirements. 
• Support for tiered access models for academic, nonprofit, and commercial users. 

 E. Program Support and Collaboration 

• Dedicated technical and project management support. 
• Coordination with the Biobank Program team and participating institutions. 
• Support for onboarding new data contributors and downstream users. 
• Participation in governance or advisory meetings as requested. 

 3. Vendor Qualifications   Responding vendors should demonstrate: 

• Experience supporting large-scale biomedical data platforms, biobanks, or research consortia. 
• Expertise in secure data management and curation. 
• Experience working with academic medical centers, research institutions, or public-sector entities. 
• Robust data security, privacy, and compliance practices. 
• Operational stability to support a multi-year engagement. 

4. Proposal Requirements   Proposals must include the following sections: 

1. Company overview and relevant experience 
2. Technical architecture and infrastructure description 
3. Approach to data ingestion, curation, harmonization, and governance 
4. Security, privacy, and compliance framework 
5. Implementation plan and timeline 
6. Pricing structure and cost transparency 
7. References from comparable programs 

 5. Evaluation Criteria   Proposals will be evaluated based on: 

• Alignment with program goals and scope 
• Technical robustness, scalability, and flexibility 
• Experience with similar initiatives 
• Strength of data governance, security, and stewardship 
• Cost effectiveness and long-term sustainability 

 6. Anticipated Timeline 

• RFP release: 1.26.26 
• Proposal submission deadline: 2.27.26 

 7. Submission Instructions 

Proposals should be submitted electronically via Submittable. Selected proposals may be invited to interview. 

 8. Term 

The engagement will be for a five (5) year term with options to renew       

9. Contact   For questions regarding this RFP, contact: BioBank@masslifesciences.com   This solicitation does not constitute an obligation to fund any proposals. The MLSC reserves the right to modify or cancel this RFP at any time and may request further clarifications or conduct interviews as part of the selection process.     

 Appendix : 

Security, Privacy, and Compliance Requirements 

Vendors must demonstrate, as applicable:   

Security 

• HIPAA-compliant data handling and storage 
• Encryption in transit and at rest 
• Role-based access control and audit logging 
• Incident response and breach notification procedures 

 Privacy 

• Separation of direct identifiers from research datasets 
• Support for data use limitations and withdrawal workflows 
• Data provenance and traceability 

 Compliance and Standards 

• SOC 2 Type II or equivalent 
• ISO 27001 or equivalent 
• Clear documentation of subcontractors and cloud providers 

 Business Continuity 

• Disaster recovery and backup strategy 
• Defined service-level commitments 

Program Overview

This program offers tax incentives to companies engaged in life sciences research and development, commercialization and manufacturing in Massachusetts in exchange for job creation. The primary goal of the program is to incentivize life sciences companies to create new long-term jobs in Massachusetts. 

Please view the details of the program including full list of eligibility requirements, resources available and evaluation process before submitting your application.

The application deadline is March 31st, 2026, at 2 p.m. EST.

You can save your application at any time and continue it later. To edit/update your submitted application, click the 'Open' button to the right of the application listed below under "My Applications," and then click on "Program Applications." Please note, each tab of the application will need to be completed prior to submission.

If you have any questions regarding this application, or experience any technical difficulties, please e-mail taxprogram@masslifesciences.com.

Program Overview

The MLSC is particularly seeking to enhance and/or expand training programs that address critical skills and talent supply gaps facing the sate’s life science industry. Such programs include those focused on Biomanufacturing, MedTech, Advanced Manufacturing, and other key careers in the life sciences ecosystem in Massachusetts. Applicants must have at-least one industry partnership that ensures that the program is responding to a direct hiring need.

Furthermore, the MLSC is committed to increasing diversity, equity, and inclusion within the life sciences workforce and will prioritize investments in programs that serve underrepresented populations.

Program Eligibility

Applicants must be a Massachusetts legally organized:

• Life Science company (“Company”) located in the Commonwealth of Massachusetts
• and regisered to do business in Massachusetts. A Certifcate of Good Standing from
• the Massachusetts Secretary of State and Certifcate of Good Standing from the
• Massachusetts Department of Revenue are required for the submission
• Community-Based Organizations (CBOs), including CBOs relying on a fscal agent
• Community Colleges, Colleges, and Universities
• Comprehensive and Vocational High Schools, including Vocational Schools ofering an
• after-hours or Career Technical Initiative evening training program
• For-Profit Entities
• Non-Profit Entities
• Municipalities
• Workforce Development Organizations
• MassHire Workforce Investment Boards and Career Centers

Please review detailed program eligibility and application evaluation process here: Eligibility and Evaluation Process

If you have any questions regarding the application process, Email: Pathmaker@masslifesciences.com