Phase IV

There are many different types of Phase IV studies, ranging from
Observational, Pharmacoeconomic, Health Outcomes, REMS (Risk
Evaluation Management Studies) to Label Expansion, and
Comparative Effectiveness. At Jubilant Clinsys Inc., we understand
the unique challenges companies are faced with in managing large
global Phase IV studies. Regulations are not explicitly defined and
often open to interpretation; however with years of experience
conducting Phase IV studies, Jubilant Clinsys Inc. is equipped to
advise on how to manage the expectations of regulatory agencies.
As legislation, public concerns about the safety of marketed
drugs, and the need to evaluate safety and effectiveness in a real world setting continue to grow, the demand and requirements for conducting late phase studies will become a critical step in the development of new drugs.

Jubilant Clinsys Inc. is experienced with call center management, DSMBs, real world physicians, web based data collection, centralized/remote monitoring, robust site management, hotline management, creative patient retention strategies, and more.

Operational Services

• Project Management
• Regulatory Services
• Drug Safety
• Biostatistics
• Data Management
• Medical Writing
• Quality Assurance

  Case Study

  Dermatology/Pediatrics – Jubilant Clinsys is conducting a Phase IV prospective longitudinal study in 8,000 pediatric patients at 500 study sites (350 in US and 150 in EU) with an expected study duration of 16 years, including the 10 year follow up period. .. As this was a “rescue” from another CRO, multiple challenges were experienced. To address slow enrollment, new sites were added, direct to physician marketing was employed, and feasibility studies were performed to qualify sites. To maximize patient retention over the 10 year follow up period, a Patient Retention Campaign was instituted. To keep sites active during the duration of the study, Active Site Questionnaires and Focus Groups were utilized. Safety management, data management and biostatistics management were all improved to accommodate the demands of the study.
  
  Quote from Chair of the DSMB:
  
  "This is to express my sincere appreciation for the superb, timely and hard work that the team, under your leadership at Clinsys, has put into this project.I have worked on many DSMBs before and frankly this team is the best I can testify to. Thanks for helping DSMB to do its job in this very important study which involves children."

   

  Publication

  Ensuring on-time quality data management deliverables from global clinical data management teams

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