Complete Pharmacovigilance Solution
A generic pharmaceutical company looked to ELC Group’s experience and expert knowledge to help reduce operational costs, meet key regulatory deadlines and ensure continuing compliance across its global portfolio of products.
A UK-based generic pharmaceutical company conducted a thorough review of its R&D activities and identified a number of regulatory compliance areas that the regulatory team felt would benefit from being outsourced to an expert support partner. Pharmacovigilance (PV) activities such as case processing and aggregate report writing were seen as key tasks to which an experienced pharmacovigilance services supplier could add insight and deliver significant value.
Following a rigorous vendor selection process, the client chose ELC Group to provide pharmacovigilance services for its portfolio of 350+ products across Europe.
ELC Group solution
Harnessing ELC Group’s international base of pharmacovigilance experts, the customer was able to seamlessly transition key activities and responsibilities to ELC Group while maintaining a high level of quality and service.
ELC Group harnessed its internationally-based team of experts to deliver a global solution. A core team of highly qualified chemists and medicine experts was quickly convened, and ELC Group’s PV Subject Matter Experts worked closely with the customer’s global PV team to plan and implement the solution and transition the key activities.
- Case processing and aggregate report writing were transitioned to ELC Group, making sure that all new processes were harmonized with the customer’s existing systems and Standard Operating Procedures (SOPs). In addition, ELC Group created detailed process documentation to complement the client SOPs and to formalise the processes to be adhered to by the ELC Group team.
- A call centre was established to operate as a 24x7 support service providing medical information, product quality and AE intake services to the customer. A freephone number is provided for calls from Europe, and all incoming calls are routed to ELC Group’s operational centre in India. A qualified team of pharmacists and HCPs have been recruited and trained on the customer’s product portfolio and are now handling all inbound medical information queries from consumers and HCPs, and documenting Adverse Events reported by consumers, pharmacists or HCPs.
- ELC Group recruited an experienced PSUR writer who was able to gradually take over and drive this function entirely, including conducting literature searches, issuing calls for contributions, generating line listings, and presentation of analysis.
- A programme of in-depth training was instituted for all team members involved in key activities – including case triage, case entry and writing case narratives, MedDRA coding, label assessment, medical review and case validation – to ensure a deep understanding of the customer’s product portfolio and processes. From the start of the engagement, all of the customer’s incoming cases were immediately transitioned to ELC Group in a seamless handover.
- ELC Group now processes over 5,000 cases and submits over 150 periodic reports annually for this customer.
- ELC Group has helped the customer to consistently achieve over 99% compliance with regulatory timelines.
- The customer has measured a more than 50% reduction in annualized costs over the first year of the solution’s operation. Case quality has been maintained throughout, and the quality of ELC Group’s work has been validated through several successful audits completed by the customer’s operations team.
- The relationship with the customer has developed very successfully, and ELC Group has now been engaged to support the customer across a range of other activities, such as making and implementing Risk Management Plans. The scope of ELC Group’s work has extended to include core areas such as submissions to the regulatory authorities and independent literature case processing.