- The pharmacovigilance industry is poised for a quantum growth in 2020
- Complexities are increasing due to new drug launches and higher degree of regulatory requirements.
- Vendor selection is a time consuming, detail oriented process that that involves some serious amount of forward thinking for any client organization.
Effective, result oriented and process driven pharmacovigilance practices are high on the list of every pharmaceutical, medical device and biotech product makers. As the overall pharma industry goes truly global in size and reach, the complexities have proportionately increased manifold. Simply outlined, any organization’s top line growth today is directly proportional to how well managed the organizations pharmacovigilance compliance practices are…as the regulatory structure, very rightly, is progressively getting more stringent as far as drug safety is concerned.
Safety concerns have initiated global regulations for submitting far more granular product information, as well as demands for new levels of clinical and safety data transparency. Outsourcing of pharmacovigilance activities has increased vastly over the last decade. The global pharmacovigilance market size is expected to reach USD 11.64 billion by 2026, according to a new report by a very respectable research group. Add to that the growing media spotlight on the pharma industry, patient safety has become the sine qua non around the development of any new therapy or device.
For the manufacturers, the requirement for strong regulatory compliance mechanisms and a very skilled talent pool of pharmacovigilance professionals has significantly increased the costs of managing pharmacovigilance activities in-house. Even for a well-funded entity, the challenge of hiring and retaining a high quality pool of pharmacovigilance professionals can be daunting.
With increased R&D focus for new, innovative therapeutic molecules, drug development activities have also increased manifold. Subsequently, this has led to increased demand for pharmacovigilance professionals and companies (CRO’s) providing such services. For the pharmaceutical companies, pharmacovigilance outsourcing results in minimizing operational costs coupled with increased focus on core strength activities.
For a pharma/biotech/device company, the entire spectrum of pharmacovigilance activities can be outsourced in one go. Or they can approach the compliance requirements by partially outsourcing certain activities to a Contract Research Organisation (CRO) of repute and with solid experience and proven track record.
What activities can be outsourced
- The entire spectrum of pharmacovigilance services, including clinical and post marketing.
- Full medical information outsourcing
- Literature searching
- EU QPPV provision
- Case processing
- Signal detection and Benefit-Risk activities
- Electronic reporting
- Medical review by dedicated team of physicians
- Safety agreement production and maintenance
- Audit preparation activities
- Aggregate reports and regulatory submission documents like : ACO/PSUR/ DSUR/PBRER/RMP/REMs/SERs
- SOP writing and updating
- Quality Management and Training
- Clinical Safety assessments and reporting
- Safety summaries
- Preparation and review of core safety documents and local documents e.g. SPC/CCDS/PI/PL
Pharmacovigilance Outsourcing Pitfalls
For many companies, the activities to select a partner/vendor begins much before they have identified what they want to outsource. They need to decide what they want to outsource much before they approach pharmacovigilance service providers…they might outsource for the full spectrum of pharmacovigilance services, do it partially or even for specific projects.
Due diligence in vendor selection is critical. The vendor has to meet all required functional, IT and financial parameters. Overall vendors experience, service delivery quality, vendor track record of past performance is non -negotiable. Vendor should ideally offer the ability to speak to existing customers to better understand their strengths. The vendors CAPA process should be brought to the discussion table and any non-conformance to the expected standards should be transparently discussed.
The team members who will deliver the actual project, their credentials and experience is of vital importance. How often are they trained with the latest changes and updates in the system? The client organization also has to look at how often they are updated by the vendor CRO about the latest regulatory changes.
Selecting the right vendor needs both the heart and the mind. Long term partnerships take effort and time to build and grow. Choosing a vendor wisely will save a lot of future heartburn for the MAH and also add real value to the whole compliance process.