Medical Affairs & Pharmacovigilance
Linical has provided medical affairs and pharmacovigilance services since 2005, covering both clinical and postmarketing drugs and devices across several therapeutic areas.
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Comprehensive Medical Monitoring and Pharmacovigilance Services
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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 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
Areas of Therapeutic Expertise
Our Clinical Pharmacovigilance Services
Services
Our Postmarketing Pharmacovigilance Services
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- 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
- Weekly or monthly literature review (as required per applicable regulatory agencies)
- Identification, assessment and processing of adverse event reports associated with your products
- 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
- 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
Leveraging the Best Technology for Your Drug Safety Database
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.
- Validated, reliable system of entry customized to each product
- Automated workflow development with advanced reporting capabilities
- Responses are provided to consumers in accordance with current product labeling and predetermined Frequently Asked Questions, standardized letters, and responses
- Documentation of product complaints (and associated adverse events, if applicable)
- Transfer to Linical PV team and/or client’s QA Department for processing
- 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
- Active monitoring of Client social media sites for identification and triage of product inquiries, complaints and adverse events
- 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
- 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.
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.
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