MEETING THE UNIQUE CHALLENGES OF POST MARKETING TRIALS … Supporting the Future
PROMETRIKA’s comprehensive phase 4 services focus on helping our sponsors in their efforts to build product awareness, investigate new indications, and fulfill post-marketing regulatory commitments.
In addition to traditional phase 4 clinical trials, PROMETRIKA designs and manages non-randomized observational trials and global patient registries.
While lifecycle management programs of approved biopharmaceuticals vary widely in complexity and approach, all post-marketing research requires a sharp focus on efficiency and on maximizing return on investment for sponsors. For more than a decade, PROMETRIKA has worked closely with medical affairs and marketing teams in large and small biopharmaceutical companies developing the necessary methodologies and perspectives required to meet the unique challenges in the design and implementation of post-marketing strategies.
We also conduct exploratory analyses of data from registration studies and generate abstracts, manuscripts, posters, and slide presentations for professional congresses and medical education meetings.
- Comparative head-to-head studies with equivalence or non-inferiority endpoints
- Non-randomized observational studies and patient registries
- Special safety studies to fulfill phase 4 regulatory commitments
- Observational marketing research
- Post-marketing safety update reports for regulatory submission
- Exploratory statistical analyses of data from marketing authorization clinical trials
- Awareness building, medical education and publication support