Late Phase Solutions Europe AB provides you with strategic and operational guidance on Late Phase Drug Development with a focus on Real World Data on orphan drugs both from an international as well as national perspective.
Examples on assignments are:
- Observational studies/ patient registries to collect real world data to fulfill the requirement of conditional market authorization or reimbursements of orphan drugs.
- Guidance and support in establishing data collection frameworks for internationallyinteroperable multi-purpose usage;
- post approval commitments
- supporting clinical research
- increase knowledge of the natural history of rare disease
- improve diagnosis, treatment and care of patients with rare diseases
- Guidance and support in the process of developing and implementing patient registry charters and governance principles in partnership with registry stakeholders as e.g. academia and patient advocacy groups.
Late Phase Solutions provide you with more than thirty years of experience from International Biotech and Pharmaceutical Industry; whereof near twenty in the orphan drug sector and late phase drug development. We have a broad network of international expertise and key stakeholders within the global orphan drug community and can therefore tailor the solution for you by partnering with relevant stakeholders.
Late Phase Solutions is a member of p4 international, a broad consortium of professionals and organizations dedicated to providing a full continuum of late stage services
More about or services
To know more about our services and how we best can meet your needs please contact us.