J-ARC Healthcare Solutions

J-ARC Healthcare Solutions: A Centre of Excellence for Real World Evidence

J-ARC, a Centre of Excellence for Real World Evidence (RWE), is a joint initiative of Actu-Real, Inc. and Jehangir Clinical Development Centre (JCDC). The joint venture will focus on collecting and analyzing real world data (RWD) generated from clinical practice to support evidence-based clinical, economic and regulatory decisions. The requirements of real-world or observational studies with respect to design, systems and processes are often different from those of randomized clinical trials. J-ARC’s experience across the continuum of clinical development and post-approval research, its efficient global delivery model and best-in-class expertise in design, conduct and analysis places it in a unique position to provide fit-for-purpose solutions for such studies. The scientific and research community including biotech, pharma, research universities and healthcare companies will benefit from this collaboration. Regulatory agencies across the world including the United States Food and Drug Administration (FDA) already use Real World Evidence to monitor post-market safety and adverse events and to make regulatory decisions. The widespread use of mobile devices and electronic health records to gather and store huge amounts of health-related data facilitates such studies further. In addition, J-ARC’s strong execution and advanced analytical capabilities will enable insightful solutions.

Why J-ARC?

When looking for solutions to challenges of study design, data, analysis and conduct, J-ARC is your preferred partner of choice, because we provide “hands-on” leadership in the development and execution of projects using a creative problem-solving approach with a proven track record of success.

• Expertise that is cross – functional and spans across the pre- and post-launch continuum
• All-encompassing solution – HERCULE™ – a modular real world data analytics platform, and services, all in a global delivery model
• Innovative solutions for patient recruitment, retention, analysis, site agreements
• Pragmatic and fit-for-purpose solution ensuring tangible and quality business outcomes
• Partnering approach and metrics-driven ownership of deliverables for strategic, long-term client relationships
• Teams specially trained to conduct studies in traditional and innovative real world study designs

Services

1) RWE Strategy
Integrate stakeholder requirements and define an RWE strategy that meets the needs of –

• Clinical development programs
• Target Product Profile
• Commercialization plans across geographies
• Comparative Effectiveness

2) Observational Studies
Conduct and execution of observational studies such as –

• Retrospective and prospective
• Patient registries, chart reviews, surveys, disease background reviews
• Burden of illness studies
• Studies to help devise strategies to improve adherence, and establish safety profile

End-to-end support for Real World studies including conceptualization and design, protocol, feasibility and site selection, study management and operations, data management, statistics, programming and medical writing

3) Technology Support

• Digitization solutions for real world data
• Healthcare data warehousing and analytics platform
• Patient support services solutions

 Allied Services

1) RWD Analytics and Evidence Synthesis

• Systematic reviews
• Meta-analyses, network meta-analyses
• Indirect treatment comparisons, propensity score matching
• Predictive modeling
• Longitudinal clinical and claims data analysis

2) Value and Evidence Communication

• Value Proposition Development
• Global Value Dossier
• Custom messaging and positioning
• Study reports, publications, posters, abstracts

 

Contact Us

• Website: j-arc-healthcare.com
• Email: [email protected]