Solutions
The IND safety reporting final rule outlines FDA’s expectations from the sponsors to take initiative in developing well defined processes for timely and accurate analysis of individual case safety reports and aggregate data for clinically meaningful reporting to the FDA during clinical development.
Challenges
- Sponsor companies are relying on an outsourced model for cost-effective approach, however, ending up compromising on the quality of data.
- Overseas outsourcing model has led to lack of cohesive approach between Sponsors and the CROs for timely review, evaluation and submission of relevant safety information.
- In the in-house model, sponsor has the entire cost burden of developing pharmacovigilance system.
iQure Model
At iQure, our pharmacovigilance experts are part of the core clinical development team allowing sponsors to make early decisions related to safety, when compared to an outsourced model.
1. US based high quality pharmacovigilance experts
Our Pharmacovigilance experts provide early assessment of reported adverse events which would help in identifying risks associated with the investigational medicinal products (by understanding the drug’s relatedness & expectedness with the adverse event) and with further discussion with the core development team they would study its impact on the drug development process.
- Pharmacovigilance Consulting
- Process Development
2. Member of the core development team
- Accurate and timely analysis of safety issues.
- Identifying early risks for developmental compounds.
- Meaningful reporting to the FDA and regulatory compliance.
- Higher chances of NDA success.
- End to end pharmacovigilance training programs.
3. Cost Advantage and Scalability
- Cost effective when compared to in-house and outsourced model.
- Wide spectrum of pharmacovigilance expertise under one roof.
iQure Advantages
At iQure, we specialize in safety monitoring and implementing pharmacovigilance systems during clinical development and post marketing surveillance. With our accessibility to resources, supported by our subject matter experts, we promise to deliver high quality output within the stipulated timelines.
Advantages for the sponsors:
At iQure, our professionals are driven and committed to provide quality oriented solutions with zero tolerance policy on non-conformities.
- Pharmacovigilance experts for clinical development and post-marketing surveillance.
- Accurate analysis of safety concerns.
- Pharmacovigilance Training.
- Medical information Call Centre.
- Assurance of Regulatory compliances.
- Increased efficiency gains and effective utilization of resources.
- Cost savings.
- Data integrity.
