Pharmacovigilance Services | Commercial Clinical PV Services | Linical

Time 2020-06-30 11:03:45

Web Name: Pharmacovigilance Services | Commercial Clinical PV Services | Linical

WebSite: http://www.clinquest.com

ID:14964

Keywords:

Commercial,Services,Pharmacovigilance,

Description:

PV ServicesLinical'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 OverviewCollecting 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 OverviewPostmarketing 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 ofclinical 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/VascularDermatologyEndocrinologyMetabolic Syndrome or DiseaseOncologyImmunologyInfectious DiseasesPain ManagementNeuroscienceOphthalmologyRare DiseasesImagingErectile DysfunctionWeight LossReproductive SystemsPharmacovigilanceLinical'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 ServicesDevelopment of Safety Management PlansPrepare supplementary documentation (SAE form, templates, etc.)Database setup and UATSafety database hostingEudravigilance registration (if needed)Medical monitoringTriage and tracking of cases for reportability with applicable regulatory agenciesFull case processing in ArisGlobal, a validated safety database used as the platform of choice by the FDAIncluding data entry, follow-up with sites, coding of adverse events and medications (MedDRA and WHO Drug), narrative writing, QC, and medical reviewPreparation of MedWatch and CIOMS formsReview and management of suspected serious adverse reactionsIndividual Case Safety Report (ICSR) processing for serious adverse events (SAEs) and other events of interestReconciliation with clinical databaseCross reporting to IRBs and ethics committeesManagement of adjudication and data safety monitoring committeesAuthor or assist with periodic and summary reports including annual reports: IND, DSUR, etc.Author Intake (via the Medical Information call center)Our Postmarketing Pharmacovigilance ServicesAdverse Event (AE) ManagementIntake (via the Medical Information call center)Triage and tracking of cases for reportability with applicable regulatory agenciesFull case processing in ArisGlobal, a validated safety database used as the platform of choice by the FDAIncluding data entry, follow-up with sites, coding of adverse events and medications (MedDRA and WHO Drug), narrative writing, QC, and medical reviewReconciliation with Medical Information call centerLiterature ReviewWeekly or monthly literature review (as required per applicable regulatory agencies)Identification, assessment and processing of adverse event reports associated with your productsAggregate Report ManagementAuthoring of cumulative safety reports such as PADERs and PSURsManagement of reporting schedules and process timelines to allow for business partner involvement and electronic publishing as neededSafety Data Exchange Agreement(SDEA) ManagementAuthoring and/or reviewing safety agreements with business partnersCorrespondence and reconciliation with partnersRegulatory ReportingManagement of Individual Case Safety Report (ICSR) submissions to regulatory authoritiesTechnologySafety DatabaseLinical 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.Contract Research Organization (CRO)Linical is an award-winning Contract Research Organization (CRO) focused primarily in oncology,vaccines infectious disease, andgeneral medicine.Patient Engagement SolutionsLinical's full-service contact center improves patient recruitment, engagement and data collection through customizable, solution-oriented services.PharmacovigilanceLinical's Pharmacovigilance group expertly manages clinical and postmarketing PV for drugs and devices, handling product safety, adverse events and reporting.Contact The PV Team

TAGS:Commercial Services Pharmacovigilance 

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Linical is a leading provider for pharmacovigilance services. We provide global clinical and postmarketing safety management for drugs and devices.

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