PV & MI Services
Linical Accelovance’s expert team has been providing Pharmacovigilance (PV) and Medical Information (MI) services since 2005 and 2001, respectively, covering clinical and postmarketing drugs and devices across several therapeutic areas. Our PV and MI teams work seamlessly to provide a one-stop solution to identify and handle your incoming product inquiries, product complaints and adverse events.
Understanding Postmarketing Surveillance
Postmarketing surveillance is the process of monitoring the safety of an approved pharmaceutical drug or medical device subsequent to its release on the market. Drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of individuals who may not have other medical conditions that can exist in the general population. Therefore, postmarketing surveillance can further refine, confirm, or define the safety of a drug or device after it is used in the general population by larger numbers of people with a wide variety of medical conditions.
Linical Accelovance utilizes a number of approaches to monitor drug safety, including spontaneous reporting from health care professionals and consumers, reports from other pharmaceutical companies, reports identified in scientific literature as well as reports identified on monitored social media sites.
Areas of Therapeutic Expertise:
- Metabolic Syndrome or Disease
- Infectious Diseases
- Rare Diseases
- Erectile Dysfunction
- Pain Management
Linical Accelovance’s pharmacovigilance (PV) team is comprised of highly trained professionals and physicians who are fully committed to establishing and maintaining a close business relationship with our clients. We will work with you to develop a customized plan to meet your safety surveillance needs and provide a dedicated project team who will meet your expectations for safety management in a professional, efficient, and cost-effective manner.
Linical Accelovance's Pharmacovigilance Services
Adverse Event (AE) Management
- Case processing in ARISg, a validated safety database
- Narrative writing
- Medical and product coding using MedDRA and WHODrug Dictionary
- Vigorous internal QC process
- Medical Review
- Unlimited follow up (as required) for additional information
- Reconciliation with Medical Information call center
- Weekly or monthly literature review
- Identification, assessment and processing of adverse event reports associated with your products
Aggregate Report Management
- Authoring of cumulative safety reports such as PADERs and PSURs
- Management of reporting schedules and process timelines to allow for business partner involvement and electronic publishing as needed
Safety Data Exchange Agreement (SDEA) Management
- Authoring and/or reviewing safety agreements with business partners
- Correspondence and reconciliation with partners
- Management of Individual Case Safety Report (ICSR) submissions to regulatory authorities
Linical Accelovance’s Medical Information (MI) team is comprised of trained professionals including nurses and pharmacists. Calls received during established business hours are answered live by an individual specifically trained on your company’s product line. The MI team is also trained in PV, and are able to respond to product inquiries, complaints and adverse events without having to transfer calls to other departments, something which is very much appreciated by reporters.
Linical Accelovance's Medical Information Services
Product Inquiry Response and Management
- Responses are provided to consumers in accordance with current product labeling and predetermined Frequently Asked Questions
Product Complaint Intake and Management
- Documentation of product complaints (and associated adverse events, if applicable) and transfer to PV team and/or client’s QA Department for processing
Adverse Event Intake
- Intake and initial data capture of safety information
- Provision of adverse events to PV for full case processing
- Regular reconciliation performed with PV of all incoming information to ensure full data transfer between groups and compliance with regulatory reporting requirements
Social Media Monitoring
- Active monitoring of predetermined social media sites for identification and triage of product inquiries, complaints and adverse events
Medical Information Response Letters
- We can perform applicable research to prepare and distribute standard responses or letters
Product Recall and Crisis Planning
- Having a plan in place and pre-trained staff on hand allows the MI Team to jump into immediate action in the event of either a planned or unplanned crisis such as a product recall
Linical Accelovance uses Aris Global’s safety database (ARISg™) for postmarketing PV case processing and report generation. The ARISg™ safety database provides all of the functionality required to manage Adverse Event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready AE reports including MedWatch 3500A, CIOMS I, and many more.
Should there be a requirement for the transfer in or out of legacy data, our PV team will work closely with you and a third party to organize the project and ensure accuracy.
Medical Information Database
Our in-house, proprietary MI database supports the data capture of triaged calls for inquiries, product complaints, and AEs. The MI database also supports processing, tracking, and listing or reconciliation reports.
The MI database is highly customizable, and all modifications are made by an in-house Database Manager who has extensive experience in working specifically with PV and MI departments and data.
Medical Information Call Center
Linical Accelovance takes pride in providing a personalized solution for every client. As part of our standard business practice, we do not use inbound automated systems which often leave callers frustrated, feeling unvalued and unable to reach their intended party. Each call to our customer lines is answered by a trained and qualified US-based individual who can interact directly with the caller and address their needs.
MI Call Center/Triage Services are facilitated through Linical Accelovance’s MI Call Center, which utilizes dedicated telephone lines for the receipt of calls. A facsimile line and dedicated email account is created for the receipt of information, and a client-specific secure File Transfer Protocol (sFTP) is established to safely transfer and manage shared documents between our team and yours.
Linical Accelovance’s MI Call Center provides live coverage between the hours of 8:00am and 8:00pm ET, Monday through Friday, with email and voicemail coverage provided during off-hours or during times of high call volumes. Holiday coverage is provided via remote monitoring of the dedicated voicemail messaging system and email; non-urgent calls/emails are responded to the next business day after the holiday and SAE calls/emails are responded to the same day. Calls received outside these live coverage hours will be automatically directed to a dedicated voicemail messaging system, and a return call will be placed to each caller within 12-24 business hours of the initial receipt of the call. Extended coverage times are available upon request.
Learn more about how we can support your project or request a quote on our services.
Looking for pharmacovigilance services for a program still in the clinical development process? In addition to postmarketing surveillance, Linical Accelovance provides pharmacovigilance services for Phase I-IV clinical trials. Learn more.