Medical Information and Safety

Medical Information and Safety

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 custom 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 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
• Learn more about our Clinical and Postmarketing Pharmacovigilance Services

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.

Areas of Therapeutic Expertise

• Cardiovascular
• Dermatology
• Endocrine
• Metabolic Syndrome or Disease
• Oncology
• Immunology
• Infectious Diseases
• Neuroscience
• Ophthalmology
• Rare Diseases
• Imaging
• Erectile Dysfunction
• Pain Management

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