PRO Services From Trial Design to Product Launch
HSG remains the world’s leading partner research organization in the consultation, design, and execution of trials for Huntington’s disease. In accordance with its mission to accelerate new treatments for HD, HSG works with leading scientific and clinical experts, patients and families, sponsors, partners in industry, foundations and academia to strengthen the quality and outcome of HD clinical trials.
Hover over the icons below to learn how we support every stage of HD trial execution.
Clinical Trial Design
Protocol, Scientific and Patient Advisory Boards
HD Landscape Assessment
Country/Site Intelligence
HD Study Landscape
HSG Credentialed HD Site Network
Established Relationships
Rapid Site Selection & Startup
Clinical Trial Execution
HD-Experienced Medical & Operational Leads
Expert UHDRS® Rater Training
Online Modules, Remote and Face-to-Face Training
Guided by Quality
GCP/ICH Compliant, Robust QMS, Inspection Ready
Advisory Services
Knowledge and Expertise to Drive Your Clinical Study Success
The Scientific Advisory Council serves as the consultative arm of HSG. This team of recognized clinical experts with highly specialized knowledge can deliver a portfolio of research advisory services to support observational, therapeutic (phase I-IV), and decentralized HD platform studies.
Every step of the way, HSG adds value by challenging the status quo, offering new and innovative approaches to meeting your clinical development goals.
Areas of Research and Development Expertise
- HD Landscape Assessment
- Preclinical Development Guidance
- Imaging Methodologies
- Biomarker Development and Implementation
- Disease Progression and Monitoring Approaches
- Digital Health Technologies
- Clinical Trial Design and Execution
- Training and Education
- Regulatory Submission
- Patient and Research Advisory Boards
- Direct-to-Patient Online Outreach
- Decentralized Clinical Trials
“HSG understands the unmet need and is committed to supporting the development of new therapies. They are experts in all aspects of clinical development including protocol design, investigator selection and training, and study conduct. Our collaboration with HSG felt like they were an extension of us.”
– HSG Study Sponsor
Project Delivery
Relationships and Experience are Key to HSG Success
At HSG, it’s all about leveraging our longstanding relationships within the HD community to help sponsors and research partners accelerate HD treatments that make a difference. The HSG Project Delivery team are prepared to support all aspects of your study from site selection and timely site activation to recruitment, retention, monitoring and preparation for regulatory audits.
Experience and Expertise
- HSG is HD-focused.
- HSG has successfully executed 40+ clinical trials in the past 30+ years, including gene therapy and surgical delivery trials.
- HSG conducted the pivotal trials that led to all three FDA-approved treatments for symptoms of HD.
- HSG can manage ancillary activities including Feasibility and Site Selection, Startup Support, Clinical Team Training, UHDRS Training, Recruitment and Retention Support, and Post-Approval Platform Studies.
- Our highly experienced team can help sponsors reach goals successfully and efficiently.
Rapid Enrollment & High Retention
HSG’s relationship and immediate access to its network of 800+ clinical HD expert members, 130+ credentialed, trial-ready sites worldwide and more than 20,000 diverse HD patients allows us to recruit and enroll quickly and attain optimal retention of study participants.
High Touch, High Value
HSG provides high-touch project delivery services, with highly accessible team members dedicated to the execution of your study. As your Partner Research Organization, our specialized team provides end-to-end study management, including dedicated project management, site management and monitoring, vendor management, and comprehensive support for participant recruitment and retention.
Clinical Study Innovation
HSG has implemented innovative approaches such as adaptive study designs, wearable sensor technologies, direct-to-participant drug delivery, direct-to-participant online surveys, virtual study visits and decentralized studies.
Increased Flexibility
Comprehensive Project Scope and Accurate Budgeting
At HSG, we strive to understand our partners’ study objectives, timelines, goals, and key deliverables upfront to build a comprehensive project plan. HSG prides itself on developing a comprehensive scope of work (SOW), budget, and corresponding study plans in an effort to reduce change orders.
“As the world’s only Partner Research Organization focused exclusively on Huntington’s disease, HSG is a trusted partner that gives us confidence in conducting our clinical trial. It is a pleasure to collaborate on this trial with true experts and leaders in HD.”
– HSG Study Sponsor
HD Expertise. Exclusive Focus. Exceptional Support.
With an exclusive focus on Huntington’s disease, HSG delivers the expertise, collaboration, and clinical support your team needs to advance the quality and outcomes of your clinical study. Reach out to the experts at HSG to discuss your HD study and clinical development plan.
