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, we add value by challenging the status quo, offering new and innovative approaches to meeting your clinical goals, while remaining responsive to study sponsors, and partners.
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
Project Delivery is Key to Our Success
At HSG, it’s all about leveraging our longstanding relationships within the HD community to help our clients and the healthcare industry accelerate treatments that make a difference. That comes with being prepared with HSG clinical research operations – the people, the protocols, the quality control, the partners, HSG sites, and participants.
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 world wide and more than 20,000 diverse HD participants 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
“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
We’re Here to Help
Reach out to the experts at HSG to discuss your HD study and clinical development plan. We have easy access to the scientific, medical, and operational HD experts that will allow us to collaborate and provide the support you need to help your team improve the quality and outcomes of your clinical trial.
