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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
Extensive literature reviews can be conducted which encompass country-specific literature databases in addition to the standard medical literature databases. Systematic reviews of literature are also available should the client require a well-defined, in-depth, structured process adequate for publication.
Medical Writing- Pharmaeconomic Reports and Medical Summaries
Our specialization in economic modelling combined with our clinical authorship experience (over 150 manuscripts published by the JSS team with a 90% acceptance rate) places us in a unique position to produce high quality health economic reports in an elegant manner with the ability to convey the desired value message simply and efficiently.
Budget Impact Analysis
We possess abundant experience building the best-in-class budget impact models. Additionally, we adapt existing models to different countries and regions. They can be individually tailored to a specific subpopulation or healthcare system based on the client’s needs.
Creation and Adaptation of Cost-Effectiveness Models
We are capable of building and adapting cost-effectiveness models to different countries and regions. They can be individually tailored to a specific audience, subpopulation or healthcare system based on the client’s needs.
Graphical User Interface
JSS’ strategic partnership with health economics graphical user interface experts allow us to provide highly customized web-based platforms for budget impact models. This equips the client with an easy method of sharing complex health economic models in an efficient, aesthetically-pleasing manner with stakeholders across the globe.
Reimbursement Submission Preparation
We prepare submissions for drug and device evaluation to reimbursement authorities around the globe. This includes collecting and synthesizing all relevant publications, data, pharmacoeconomic evaluations and clinical summaries in the preferred format as well as completing all specific submission forms. For medical devices and products sold in hospitals, submissions tailored to hospitals and other decision-makers are performed.
Validation Session and Panel Meetings
Our recruitment strategy has been vital in the successful addition of valuable key opinion leaders or former decision-makers to our projects. We have a breadth of experience ranging from efficient one-on-one validation sessions via web conferencing systems to forming advisory boards to simultaneously engage stakeholders from across the globe in one face-to-face panel meeting. Our organizational ability permits us to successfully execute meetings of various magnitudes to match the client’s needs.
Literature Review
Extensive literature reviews can be conducted which encompass country-specific literature databases in addition to the standard medical literature databases. Systematic reviews of literature are also available should the client require a well-defined, in-depth, structured process adequate for publication.
Consulting
We have knowledgeable leaders who perform assessments and provide support during in-person meetings with stakeholders in a variety of languages. Our team possesses a combination of graduate-level scientific training, experience in multinational pharmaceutical companies and health technology assessment organizations. We can offer a client-facing individual who can provide strategic positioning with or without the use of highly experienced and specialized strategic partners.
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
Multivariate analyses, Repeated measures analyses, Decision trees/recursive partitioning, Simulation, PK/PD, Other
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
The JSS Clinical Development Team can offer consultation and advice on the strategic path of your clinical study accross many therapeutic areas. This includes early and late phase development for drugs, medical devices and nutraceuticals.
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.
Read MoreAbout Us
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
