Consultancy
WEP Clinical’s consultancy service draws on our expertise and experience providing specialist services in the biopharmaceutical industry. We take pride in our ability to stay ahead of the latest developments and help ensure customers know how best to navigate the potential challenges ahead. Whether your needs are more aligned to the EAP/PA-NPP space, or clinical trial sourcing, WEP Clinical can meet all your consultancy needs.
EXPANDED ACCESS & Post-Approval NAMED PATIENT CONSULTANCY
Expanded Access Programs (EAPs) and Post-Approval Named Patient Programs (PA-NPP) are rapidly becoming an important part of any successful development plan. However, it can be hard to understand how these programs work and how best to implement one to meet your company’s needs.
To successfully run an EAP or PA-NPP, sponsors will need to understand the complexities involved in moving into new markets before marketing approval is received. We use our extensive experience to help you bridge the gap before commercialization. WEP Clinical can provide guidance on:
- Developing a policy for allowing access to medicines in countries where they are not yet approved
- Consistency across different territories
- KOL engagement
- Managing patient requests and expectations
- Navigating the diverse, global regulatory landscape
- Managing the logistics of distributing product around the world
- Mitigating risks and any potential legal issues
- How to navigate HIPAA regulations and handle confidential patient information
- Developing a policy for allowing access to medicines in countries where they are not yet approved
- Consistency across different territories
- KOL engagement
- Managing patient requests and expectations
- Navigating the diverse, global regulatory landscape
- Managing the logistics of distributing product around the world
- Mitigating risks and any potential legal issues
- How to navigate HIPAA regulations and handle confidential patient information
CLINICAL TRIAL SOURCING CONSULTANCY
It is more important than ever before for companies to be able to access pharmaceutical products from safe, efficient and reliable sources. Equally important is the need for companies to recognize that issues in procurement and delivery of product often arise, and a successful company must be able to manage these issues so as not to disrupt clinical trial efforts or product development.
Drawing on our vast experience supplying/sourcing and distributing comparator and innovator (RLD) pharmaceutical products on a global scale, WEP Clinical can offer guidance on the following:
- Creating clinical trial protocols to allow for the most efficient sourcing of comparator product
- Identifying and vetting supply sources
- Quantifying your projected comparator supply cost
- Understanding guidelines for shipping and logistics both internationally and domestically
- Understanding importing and exporting documentation and requirements
- Managing supply issues and interruptions
- Creating clinical trial protocols to allow for the most efficient sourcing of comparator product
- Identifying and vetting supply sources
- Quantifying your projected comparator supply cost
- Understanding guidelines for shipping and logistics both internationally and domestically
- Understanding importing and exporting documentation and requirements
- Managing supply issues and interruptions
REAL WORLD DATA CONSULTANCY
“Harnessing the real patient experience”
Collecting valuable and regulatory compliant Real-World Data (RWD) for the generation of Real World Evidence (RWE) is a complex and multifaceted process. Our consultancy offering in this space will draw on our experience to help you understand the following:
- What type of data can be captured
- What tools and methods can be used to capture data
- How to analyze RWD and draw meaningful conclusions
- How to present RWD to regulatory review boards
- How to navigate HIPAA regulations and handle confidential patient information
- What type of data can be captured
- What tools and methods can be used to capture data
- How to analyze RWD and draw meaningful conclusions
- How to present RWD to regulatory review boards
- How to navigate HIPAA regulations and handle confidential patient information