Pharmacovigilance

PV Services

Linical's expert team has been providing Pharmacovigilance (PV) services since 2005, covering both clinical and postmarketing drugs and devices across several therapeutic areas. Our PV team provides a one-stop solution to identify and handle your safety management needs. We are a leading pharmacovigilance provider with global bandwidth for clinical safety management as well as postmarketing product inquiries, product complaints and adverse events. Linical uses cutting edge systems to enhance efficiency, ensure compliance, and help reduce the cost of safety data processing, and while delivering the hands-on, personalized service your project deserves.

Clinical Surveillance Overview

Collecting and analyzing safety data is a crucial component of any clinical trial, seeing as clinical trials must establish safety as well as efficacy. It is critical that safety data is handled properly to ensure the accuracy of that data, achieve regulatory compliance, and safeguard patients.

Linical's team of seasoned professionals manage safety requirements for clinical trials across the globe and an extensive range of therapeutic areas. We use a powerful platform, ArisGlobal’s LifeSphere®, to ensure consistent safety processes across all studies and meet applicable regulatory deliverables. Our experienced staff of health care professionals and safety agents have a long tenure with our organization, providing our clients with consistency and stability. We work with you from start to finish, developing a Safety Management Plan and ensuring that your study meets regulatory requirements for safety as well as the highest medical and scientific standards.

Postmarketing Surveillance Overview

Postmarketing surveillance is the process of monitoring the safety of an approved pharmaceutical drug or medical device subsequent to its release on the commercial 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 utilizes a number of approaches to monitor drug and device 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:

• Cardiology/Vascular
• Dermatology
• Endocrinology
• Metabolic Syndrome or Disease
• Oncology
• Immunology
• Infectious Diseases
• Pain Management
• Neuroscience
• Ophthalmology
• Rare Diseases
• Imaging
• Erectile Dysfunction
• Weight Loss
• Reproductive Systems

Pharmacovigilance

Linical'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 pharmacovigilance and 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.

Our Clinical Pharmacovigilance Services

• Development of Safety Management Plans
• Prepare supplementary documentation (SAE form, templates, etc.)
• Database setup and UAT
• Safety database hosting
• Eudravigilance registration (if needed)
• Medical monitoring
• Triage and tracking of cases for reportability with applicable regulatory agencies
• Full case processing in ArisGlobal, a validated safety database used as the platform of choice by the FDA
• Including data entry, follow-up with sites, coding of adverse events and medications (MedDRA and WHO Drug), narrative writing, QC, and medical review

• Expedited regulatory reporting for SUSARs
• Preparation of MedWatch and CIOMS forms
• Review and management of suspected serious adverse reactions
• Individual Case Safety Report (ICSR) processing for serious adverse events (SAEs) and other events of interest
• Reconciliation with clinical database
• Cross reporting to IRBs and ethics committees
• Management of adjudication and data safety monitoring committees
• Author or assist with periodic and summary reports including annual reports: IND, DSUR, etc.
• Author Intake (via the Medical Information call center)

Our Postmarketing Pharmacovigilance Services

Adverse Event (AE) Management

• Intake (via the Medical Information call center)
• Triage and tracking of cases for reportability with applicable regulatory agencies
• Full case processing in ArisGlobal, a validated safety database used as the platform of choice by the FDA

• Including data entry, follow-up with sites, coding of adverse events and medications (MedDRA and WHO Drug), narrative writing, QC, and medical review
• Reconciliation with Medical Information call center

Literature Review

• Weekly or monthly literature review (as required per applicable regulatory agencies)
• 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

Regulatory Reporting

• Management of Individual Case Safety Report (ICSR) submissions to regulatory authorities

Technology

Safety Database

Linical uses ArisGlobal’s safety database (LifeSphere®) for pharmacovigilance case processing and report generation. The ArisGlobal safety database provides all of the functionality required to manage clinical and postmarketing safety management globally. Linical is equipped to handle 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.

Through modeling LifeSphere® within our organization, we can provide pharmacovigilance services to clients of all sizes, ranging from more customized safety processing services to higher volume, more automated data sets. We combine our pharmacovigilance team’s therapeutic expertise with LifeSphere’s® artificial intelligence (AI) and robotic process automation (RPA) to offer clients a cutting edge solution increasing compliance, reducing time to market, and controlling drug development costs. Not only does this provide benefits to our clients, but this also helps in our commitment to ensuring long term patient safety and corporate regulatory compliance.

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.

Learn more about how we can support your project or request a quote on our pharmacovigilance services. Contact Us.