Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems1, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.
Choosing your Pharmacovigilance service provider is a crucial component of your journey towards successfully delivering life-changing treatments to patients who need them. With so many options to consider, how do you decide who to entrust with the safety information from patients who receive your product? Changing your Pharmacovigilance provider in the middle of a study can be disruptive to the sites, resource intensive for the study team, and costly, so it is best to take care and choose the best provider for your specific needs. Consider the following factors:
Compliance
To develop, manufacture, and commercialize a new therapy as well as maintain the product on the market, strict requirements must be adhered to, with the primary focus being patient safety. To ensure compliance with various regulatory authority requirements, there are numerous laws, regulations, and guidances that must be understood and used in the implementation of a Pharmacovigilance program. At PROMETRIKA, we have highly experienced staff who understand what you need to maintain global Pharmacovigilance compliance in this complex regulatory landscape, and the tools to make it happen. We have mechanisms in place (attendance at relevant conferences, routine reports from our Senior Regulatory Affairs Advisor) to stay up-to-date on regulatory requirements across the globe.
Quality
Quality impacts every aspect of Pharmacovigilance: whether you are authoring a Safety Management Plan, designing your safety database, processing safety case information, or submitting reports to regulatory authorities. It is not enough to simply complete these deliverables; they must be completed at a high level of quality for your program to be compliant and run smoothly. Attention to quality during all stages of your Pharmacovigilance program is critical to ensure compliance, patient safety, and data integrity. PROMETRIKA believes in the investment of time to do things right the first time; To quote our Quality Director, “We don’t have time to rush”.
Individual needs
Every Sponsor is different. Every program or protocol is different. Every therapeutic product is different. Therefore, a Pharmacovigilance provider that can tailor their activities to your program’s needs is important. PROMETRIKA is small enough to be flexible and our offerings cover a wide range of options, with the flexibility to individualize your program based on your needs: the unique attributes of your product, indication, company and internal resources and processes.
We develop processes and regular deliverables to give you oversight of your Pharmacovigilance program, but we also understand there are situations when you need unique listings or ad-hoc information. Our flexibility allows us to quickly respond to such requests and swiftly implement the necessary changes.
Integration with other departments
Pharmacovigilance has been built into multiple other activities, optimized when there is collaboration with other departments. Using a full-service CRO will streamline this collaboration, versus using a separate vendor for standalone Pharmacovigilance services. PROMETRIKA is not a company of silos as many large CROs tend to be. We are one machine with individual gears all working together to operate efficiently. All of our departments regularly interact and each considers the implications every decision might have on the others. When setting up your Pharmacovigilance program, we work with other departments such as:
- Clinical Operations to reduce site burden and improve communication with investigators,
- Data Management to build electronic serious adverse event (SAE) forms and ensure consistency with the clinical database,
- Statistics to ensure the data collected will be assessable,
- Medical Writing to author required periodic reports such as DSURs and PBRERs, and
- Regulatory Affairs to ensure compliance.
This cross-functional partnership between departments is especially efficient when PROMTERIKA performs your other services as well. When you work with a full-service CRO whose Pharmacovigilance team considers the implications on your program as a whole, you will be set up for success.
Culture and fit
When we are your Pharmacovigilance provider, we don’t think of ourselves as a vendor; we become integrated as part of your team. Your patients are our patients, and your success is our success.
1 Pharmacovigilance: Ensuring the Safe Use of Medicines. Geneva,.
WHO, October, 2004
www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
