RESPONSIVE
RELIABLE
RESULTS
GD3 will exhibit at the NIH Fall Research Festival | September 23 – 25, 2024 | NIH Main Bethesda, Campus
Our Services
JSS Medical Research is a full service clinical research organization (CRO) with strong academic affiliations offering a wide range of services internationally. One of our distinguishing attributes is our methodological knowledge and expertise in the design and execution of clinical studies. These include all phases of development such as Phase I, II and III, and post-approval studies. The breadth of our experience enables our clients to collaborate with the same partner throughout the product lifecycle.
- Clinical Trials
- Market Access & HEOR
- Consulting
- Biostatistics and Medical Writing
- Insourcing
- Additional Services
The JSS team provides clients with a flexible, best-in-class approach to improve cycle times, attenuate costs and reduce risks.
Clinical Phase I-III
Experience in Phase I-III Clinical Trials ranging from small to large complex multinational projects.
Clients benefit from the planning, execution and proactive management of clinical programs designed to succeed.
Late & post-approval phase
Post-approval objectives can easily be attained by careful design and execution.
Literature Review
Medical Writing- Pharmaeconomic Reports and Medical Summaries
Budget Impact Analysis
Creation and Adaptation of Cost-Effectiveness Models
Graphical User Interface
Reimbursement Submission Preparation
Validation Session and Panel Meetings
Literature Review
Consulting
Consulting
As a fully intergrated CRO, we offer a complete range of services including consultation services.
Investigator-Initiated Studies
In-Sourcing Mandates
Project Managers
Research Associates/Assistants
Epidemiology & Biostats Courses
Demystifying Statistics Part I
Demystifying Statistics Part II
The Architecture of Clinical Research
Post Approval Research
Health Economics and Outcome Research Made Simple
Review, Critique and Synthesis of the Literature
Customized Courses
Clinical Research Consulting
Regulatory
Clinical Development Plan
Study Design
Needs Assessment
Protocol Development
Regulatory Consulting (HC,FDA,EMEA)
QA Services
Compliance Consulting
SOP Development
Auditing
Software Validation
GCP Training
General ICH-GCP
ICH-GCP for Investigators
Biostatistics
OUR EXPERIENCED BIOSTATISTICIANS AND STATISTICAL PROGRAMMERS PROVIDE CUTTING EDGE ANALYSES AND INSIGHTS TO SPONSORS
Analysis Dataset Generation
Tables, Figures and Listings Development
Sample Size Calculations
Advanced Biostatistics
Epidemiological expertise for post-approval studies
CDISC SDTM & ADaM Mapping / Programming, and development of define.xml
Verification / Quality Control / Validation of Statistical Programming
SAS Macro Development
Medical Writing
Whether related to early-phase or post-approval studies, our medical writing experts deliver quality documents that are clear, concise, scientifically accurate, and compliant with regulations, industry standards and the Sponsor’s internal guidance.
Our Medical Writers have experience in a wide range of indications & therapeutic areas, study designs, and medical writing deliverables, as well as a proven publication track-record.
Insourcing
JSS performs insource services with highly qualified, trained and educated personnel knowledgeable in ICH and GCP, varied therapeutic areas, applicable regulatory requirements and pharmacovigilance expertise.
Clinical Development Plan
Strategic Assessments
Risk Management
Patient Reported Outcomes
Literature Review
Advanced Biostatistics and Rescue Analysis
JSS Medical Research: Evolution of Clinical Epidemiology – Behind the Scenes on PBS television
Global Coverage
JSS offers global coverage with offices in all major continents to deliver consistently excellent operations with full-time permanent and locally-based staff. This allows us to execute studies that meet global quality standards around the world.
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JSS Medical Research
Commitment to scientific excellence to support the approval and reimbursement of life saving therapies
Our Clients
JSS Medical Research provides comprehensive clinical trial management services, from study design to publication of results, in Phase I-IV trials across a broad range of therapeutic areas to the global pharmaceutical, biotechnology, medical device and nutraceutical industries.
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Mission: To conduct health research recognized as the standard of excellence.Vision: To link industry, academia, regulatory authorities, payers, and patients through our scientific foundation.
Values: Accountability, responsiveness, results-oriented, teamwork, respect, and reliability.
Meet our Executive Team