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Global

JSS Medical Research has evolved from a local Canadian CRO to an international full service CRO with study involvement in over 21 countries. Through our corporate head office in Montreal (Canada), our regional offices in Bogotá (Colombia), New Delhi (India), Warsaw (Poland), Vancouver (Canada) and Boston (USA), as well as our global network of partners, JSS Medical Research conducts clinical research in North America, Latin America, Europe, the Middle East, and Asia.

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Regional

Our expansion into India, Colombia and Poland enables us to provide our services to large pharmaceutical clients, and their regional affiliates, in the emerging Indian and Latin American markets, as well as the established European markets. For our biotech clients, our expansion has provided them with access to academics, key opinion leaders, and investigators. This facilitates the completion of their clinical development programs and helps them gain access to these important markets.

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People

Our success depends on the quality of our people. JSS Medical Research has the necessary critical mass of highly trained professionals from North America, Latin America, Asia-Pacific, and Europe. Our customer-centric approach allows us to provide our clients with the highest quality services covering all the scientific and operational aspects of clinical research.

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Our Clients

JSS Medical Research, as an international mid-tier niche CRO, is large enough, yet nimble enough, to work with a diverse group of clients including global pharmaceutical, biotechnology, medical device and nutraceutical industries. Biotechnology companies rely on the company's knowledgeable project teams, and its customer-centric and flexible approach, to successfully conduct their critical early phase trials, while pharmaceutical companies can leverage its niche post-marketing service offerings.

RESPONSIVE

We offer creative solutions. You can count on us.

RELIABLE

Our clients think so. They keep coming back.

RESULTS

What you're looking for. What we deliver.

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. This breadth of our experience enables our clients to collaborate with the same partner throughout the product lifecycle.

The JSS team provide clients with a flexible, best-in-class approach to improve cycle times, attenuate costs and reduce risks.

Clinical Phase I-III

Experience in Phase II-III Clinical Trials ranging from small to larger complex multinational projects.

Clients benefit by the planning, execution and proactive management of clinical programs designed to succeed.

Phase I
Phase II
Phase III-IIIb
Medical Devices

Late & post-approval phase

Post-approval objectives can easily be attained by careful design and execution.

Phase IV
PMOS
Paces
Chart Review
Registries
Databases Analysis
Epidemiological Surveys

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.

Medical Writing – Pharmacoeconomic Reports and Clinical Summaries

We are frequently requested to author pharmacoeconomic reports and compelling clinical summaries in conjunction with building economic models. As such, our specialization in economic modelling combined with our clinical authorship experience (over 100 manuscripts published by 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.

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.

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.

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

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 & Biostatistics 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

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Medical Writing

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.

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Insourcing

JSS performs insource services with highly qualified, trained and educated personnel knowledgeable in ICHand GCP, varied therapeutic areas, applicable regulatory requirements and pharmacovigilance expertise.

Additional Services

Regulatory

The JSS Regulatory Affairs unit offers operational and consulting services ensuring that studies will be compliant with all of the regulations and laws pertaining to their country and state. Experience with Regulatory agencies include the Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA) and other globally.

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

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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About Us

Built on a foundation of epidemiological and scientific expertise, with a strong network of academic affiliations and over 25 years of experience in multiple therapeutic areas.

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STAY UP TO DATE ON EVERYTHING HAPPENING AT JSS

Our Location

9400 Henri-Bourassa Blvd. West St-Laurent (Montreal) Quebec H4S 1N8

+1 514-934-6116

inquire@jssresearch.com