Pharmacovigilance
Amanda Cahalane |
AKOS provides Global Pharmacovigilance services covering clinical trials from Phase 1 throughout the development cycle through to full post marketing support.
We provide tailored and flexible support to suit the needs of clients in a variety of therapeutic areas covering Medicines, Devices, Biotechnology and Vaccines.
The PV teams are currently located in Harpenden, UK and RTP, North Carolina which facilitates provision of our global services.
Clinical Trials (expertise in EU, USA, ROW)
AKOS provides a full range of clinical trial Pharmacovigilance services from initial registration with EudraVigilance through to handling clinical trial ICSRs and aggregate reports.
- ICSRs: We can receive, process, track and report your ICSRs. This includes MedDRA coding, full Q.C. narrative writing, requesting of follow up and medical review.
- Safety Database (i.e. AKOS ARISg in-house OR remote entry into sponsor database): There are three options for handling your ICSRs.
- We can provide you with your own ARISg database for entry of your ICSRs . This will facilitate safety oversight and reconciliation.
- We can enter ICSR data into your own in house database according to your own conventions and SOPs.
- We can prepare ICSRs using a manual process which gives you a lower cost option if small volumes of SAEs are expected.
- EudraVigilance/electronic submissions: We offer the facility to report ICSRs to EudraVigilance and Competent Authorities in Europe and this can be done with or without us supporting the full case management process. We also support reporting to USA and Canada as well as Asia Pacific and, South America.
- Responsible Person (RP) for EudraVigilance: We have a long history of acting as the RP for many clients and can ensure you are complying with the legislation as well as making the registration process as quick and easy as possible.
- Aggregate reports: We can prepare 6 monthly and annual reports for both EU and FDA requirements. Alternatively we can simply submit them on your behalf.
- Reconciliation: We will ensure that reconciliation is done on an ongoing basis with your clinical database which will ensure no delay as the end of the study.
- Project Management: We will ensure that each client has a nominated lead who acts as the key point of contact for all communication. This same person will manage the deliverables for the client and ensure that activities are delivered to expected standards.
Post Marketing Pharmacovigilance (EU, USA, ROW)
We offer full Post Marketing Pharmacovigilance services including full case processing and reporting, preparation of aggregate reports, signal detection and literature search and review.
- ICSRs: We can receive, process, track and report your ICSRs. This includes MedDRA coding, full Q.C. narrative writing, requesting of follow up and medical review.
- Safety Database: There are three options for handling your ICSRs.
- We can provide you with your own Aris g database for entry of your ICSRs. This will facilitate safety oversight, reporting writing and reconciliation.
- We can enter ICSR data into your own in house database according to your conventions and SOPs.
- We can prepare ICSRs using a manual process which gives you a lower cost option if small volumes of SAEs are expected.
- EudraVigilance/electronic submissions: We offer the facility to report ICSRs to EudraVigilance and Competent Authorities in Europe and this can be done with or without us supporting the full case management process. We also support reporting to USA and Canada as well as Asia Pacific and, South America.
- Aggregate Reports: We prepare EU PSURs and FDA Periodic Reports. This involves generation of line listings and QC of the associated data, writing and compilation of the report which as well as medical review.
- Literature Search and Review: AKOS uses Ovid as a platform for Literature Searches. We have expertise in setting up a suitable and compliant literature search for your products. We run searches for clients on a weekly basis and review the output for ICSRs and relevant safety information. All of this is recorded either in the safety database or safety log, for future use.
- Signal Detection: We run and review data listings for your specified products and work to your signal detection process or work with you to develop a tailored process for your needs.
- Project management: We will ensure that each client has a nominated lead who acts as the key point of contact for all communication. This same person will manage the deliverables for the client and ensure that activities are delivered to expected standards.
Therapeutic area expertise
We have worked with a broad range of clients in areas such as gene therapy, dermatology, oncology, gynaecology, vaccines, neurology.
Devices
We have worked with a number of clients supporting Device vigilance both where a medicine is involved and also where the product is a device only.
Expertise and experience in Global Regulatory requirements for PV
As we have many years of experience working globally and particularly in USA and EU we have a comprehensive set of up to date Pharmacovigilance Regulatory requirements.
Legacy data projects
We have expertise in handling legacy data, whether a large or small project, and have developed legacy data handling plans to facilitate this process. It helps us to identify potential pitfalls that sometimes get overlooked by those inexperienced in handling legacy data.
Ad hoc PV projects
We have worked with clients in a number of different Ad hoc situations sometimes post inspection, in times of a high volume of activity or post merger. We can support companies in all aspects of PV and will work with you to develop a tailored and cost effective solution.
Clinical Trial Pharmacovigilance Download information pack
Post Marketing Pharmacovigilance Download information pack