Explore the critical challenges in pharmacovigilance and compliance within clinical trials, with insights on how biotechnology and pharmaceutical consulting firms in Boston can help improve adherence to regulatory standards.
Given the need to bring safe drugs to the clinic, it is alarming to find from recent studies that fewer than one in five compliance requirements with pharmacovigilance laws ever met regulatory standards. Such non-adherence represents a major threat to patient safety and the viability of drug development programmes. So, here we discuss the pressing challenges and steps required to enhance compliance in the field of pharmacovigilance in Boston, turning our attention to the biotechnology and pharmaceutical consulting sector.
Compliance Challenges in Pharmacovigilance
Data management
One of the key contributory factors for ADR Monitoring. When it comes to huge data sets, most firms face challenges in combining data from different sources and analyzing it.
Regulatory Awareness:
Awareness and adaptation to regulatory changes remains an ongoing pain point. Compliance requires knowledge of changing guidelines and the ability to adjust accordingly.
Reporting Systems:
The effective ADR reporting systems are mostly absent, resulting into underreporting and delayed response time.
Insufficient Training and Resources:
Noncompliance is also caused by inadequate trainings and the lack of resources allocated for the pharmacovigilance teams.
Use of Technology: With the assistance of modern technology, pharmacovigilance can work more efficiently; nevertheless, not every organization is up to speed with them.
Enhanced Compliance with Pharmacovigilance
Here are some steps that can be taken to overcome the problem of low compliance in clinical trials −
Improved Training Program:
Frequent training & education of pharmacovigilance teams on the updated regulation & best practices.
Improved Data Analytics:
Using advanced data analytics tools to better analyze and interpret the pharmacovigilance data.
Automated reporting systems:
Under the use of automated system for real-time reporting and monitoring of ADR.
Audits and Assessments on a Regular Basis: Periodically conducting internal audits to discover and correct compliance gaps as early as possible.
Working with Consulting Firms: Partnering with specific consulting firms that can provide expertise on better pharmacovigilance.
Conclusion
More recently, pharmacovigilance bar has been set quite low, with only less than 20% compliance. Ensuring drug safety in clinical trials has become a complex but extremely important task. Through proven solutions to the major problems and the experience of biotech, pharma and life science consulting companies in Boston, firms can bring about an increased compliance rate which will in turn help ensure the availability of safer and effective drugs to patients.
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