With increasing regulatory demands in India , it has become mandatory for all the pharmaceutical companies to conduct Phase IV and/or Post Marketing Surveillance Clinical Trials for the drugs with FDC.
We at Pharmatrendz has started a cost effective solution for all companies to conduct clinical trial of FDC with single point of contact for the pharmaceutical Industry . As an expert in clinical trials and regulatory affairs in all type of indications,.
we would be the preferred service providers, as all the requirement can be full filled under one roof.
Our 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, We designs and manages non-randomized observational trials and Indian 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.
We work 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 conferences and medical education meetings.
OUR SERVICES
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- 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 obligations
- 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
- Post Marketing Literature Surveillance
- AE Monitoring & Reporting Services