c-shape
CLINICAL TRIAL MANAGEMENT

Medical Affairs & Pharmacovigilance

Linical is a leading global medical affairs and pharmacovigilance provider, offering a one-stop solution to identify and handle your medical consulting and drug safety management needs.

Linical has provided medical affairs and pharmacovigilance services since 2005, covering both clinical and postmarketing drugs and devices across several therapeutic areas.

Services

Comprehensive Medical Monitoring and Pharmacovigilance Services

Linical's expert team has been providing medical monitoring and 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 medical consulting and PV service 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.

Explore

Clinical Surveillance and Medical Monitoring 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 an industry-leading global platform (21 CFR Part 11 compliant and validated) 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.

Highly Trained Medical Affairs Experts

Linical's medical affairs team is composed 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 drug safety management in a professional, efficient, and cost-effective manner.
Right Size
Right Reach
Right Team

Areas of Therapeutic Expertise

Do you need a therapeutically focused medical expert to assist with your drug development journey? Linical provides experienced medical consulting services across the following therapeutic areas:

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 a robust global safety database
(21 CFR Part 11 validated and compliant) - 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

Services

Our Postmarketing Pharmacovigilance Services

Explore

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 a 21 CFR Part 11  validated safety database 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

Leveraging the Best Technology for Your Drug Safety Database

Linical uses an industry-leading safety database (21 CFR Part 11 validated and compliant) for pharmacovigilance case processing and report generation. This robust 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.
Providing Pharmacovigilance Services for Clients of All Sizes
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.
Therapeutic Expertise and AI
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.
Transfer of Legacy data
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 Services

A major asset to our clients is the versatility of consumer services at Linical. Linical utilizes several 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. Our specialists are trained to identify safety events and product quality complaints in addition to being fluent in Data Privacy, Good Clinical Practices, Linical SOPs, and project specific documents.

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.

Our MI (Medical Information) team works seamlessly in conjunction with Linical PV (Pharmacovigilance) to provide a one-stop solution to identify and handle your incoming product inquiries, product complaints and adverse events.

Secure Data Entry Platform
  • Validated, reliable system of entry customized to each product
  • Automated workflow development with advanced reporting capabilities
Product Inquiry Response and Management
  • Responses are provided to consumers in accordance with current product labeling and predetermined Frequently Asked Questions, standardized letters, and responses
Product Complaint Intake and Management
  • Documentation of product complaints (and associated adverse events, if applicable)
  • Transfer to Linical 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
  • Reconciliation cadence performed with PV to ensure full data transfer between groups and compliance with regulatory reporting requirements
Social Media Monitoring
  • Active monitoring of Client social media sites for identification and triage of product inquiries, complaints and adverse events
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
Secure File Transmission Portal
  • 21 CFR Part 11 compliant portal for safe file transmission to Clients
  • Validated, secure data storage and sharing
  • Robust encryption and access controls
  • Securely retain and archive content based on folder location, keywords, metadata, or sensitive content to meet legal and regulatory requirements.
Linical
OUR BENEFITS

Why Linical?

The clinical development journey can be daunting and often leads to failure. With so much riding on your compound, you deserve the best chance at achieving your goals and positively impacting patients across the globe.

As a global, award-winning CRO, we can provide the strategy and support you need to position your clinical trial for success. We have an impressive track record of exceeding our enrollment goals and maintaining nearly a 90% client retention rate.

With our collaborative approach and commitment to quality, Linical expertly guides you through each step of the process, from early-phase research to large-scale global studies. With Linical, you can overcome obstacles, expedite timelines, save valuable money, and achieve your goals without compromising quality.

Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

cta-img (2)