Services2019-01-21T11:21:41+00:00
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Clinical Trial Set-Up and Management

We provide comprehensive support in setting up and managing international clinical trials and medical device investigations in the Baltics – from initial study feasibility and clinical trial applications, through to routine monitoring and site management, up to query resolution and site closure. We work in full compliance with GCP guidelines, applicable international and local regulations, ethical standards, and can support you with all country-level clinical research activities in Lithuania, Latvia and Estonia:

  • Study feasibility, site identification and selection

  • Collection of necessary documents from sites

  • Clinical Trial Application review, preparation and adjustment

  • Regulatory submissions to Ethics Committees and Regulatory Authorities

  • Local project management

  • Site Initiation Visits

  • Site Monitoring Visits (clinical trial monitoring)

  • Site Close-Out Visits

  • Site Activation Visits and Quality Check Visits

  • On-site training

  • Site interaction and support

  • Site file maintenance

  • Query management

  • Drug accountability, IMP and other material coordination

Site Management & Support Services

Let the investigators focus on treating the patients, we will handle the rest. Our experienced Site Coordinators can remove the administrative clinical trial burden from the investigators allowing them to concentrate on enrolling and treating patients. Depending on Sponsor’s and Investigator’s requirements we can work both on-site and remotely, assisting with:

  • Patient recruitment & retention activities

  • Coordination of patient visit schedule (tracking, scheduling, reminding, etc.)

  • Management of clinical trial materials, lab-kits and study medications

  • Management of couriers and shipments (lab samples, dry-ice, etc.)

  • CRF data entry and query resolution

  • Investigator Site File management

  • Maintaining communication with all parties on behalf of the site

  • Preparation for and assistance during monitoring visits and site audits/inspections

We help life science companies meet their pharmacovigilance obligations by establishing and maintaining state of the art pharmacovigilance systems. Our highly experienced and trained PV professionals can support you with any individual PV activity as well as implement our comprehensive PV system as a full solution.

    Local Pharmacovigilance Services

    Our experienced team of Local Safety Officers (LSO) / Local Persons for Pharmacovigilance (LPPV) represent MAHs on country-level in Lithuania, Latvia, Estonia, Finland, Sweden, Norway, Denmark, Iceland.

    • Provision of Local Safety Officers / Local Persons for Pharmacovigilance (LPPV/LQPPV)

    • Named Deputy LPPV and 24/7 availability

    • Weekly local medical and scientific literature screening

    • Support in creation and maintenance of local PV systems (local SOPs, etc.)

    • Local PV regulatory intelligence and consultations on applicable laws and legislation changes relating to PV

    • Collection and processing of safety information on country-level from any source (literature, local safety mailbox, phone enquiries, etc.)

    • Medical Information inquiries handling in local languages, including 24/7 customer-specific hotline

    • PV training of local affiliates (e.g. sales teams, etc.)

    • Local support with implementation of Risk Minimisation Measures (Educational Materials, DHPC communications, etc.)

    • Handling of National Competent Authority requests and inspections

      EU/EEA Pharmacovigilance System

    • Set-up and maintenance of Pharmacovigilance System and Pharmacovigilance System Master File (PSMF)

    • EU/EEA Qualified Person responsible for Pharmacovigilance (EU-QPPV) and Deputy QPPV

    • EudraVigilance registration and maintenance, including medicinal product data reporting to XEVMPD

    • Processing and reporting of Individual Case Safety Reports (ICSRs)

    • E2B and CFR21 compliant Safety Database

    • Global and local literature monitoring

    • Signal detection and management

    • Development and submission of Risk Management Plans (RMPs), as well as implementation of risk minimization measures (DHPC, educational materials)

    • Development and submission of Periodic Safety Update Reports (PSURs)

    • Pharmacovigilance audits and inspections handling

    Regulatory Affairs Services

    Our comprehensive regulatory affairs services are dedicated to help our customers achieve maximum compliance and timely approvals in marketing their pharmaceuticals, medical devices, cosmetics and food/dietary supplements. We specialize in country-level regulatory support and can assist you from initial marketing authorization applications through to complete product life cycle maintenance:

    • Dossier gap-analysis, documentation compliance review

    • Marketing authorization applications (National Procedure and DCP/MRP applications)

    • Obtaining a DCP slot with one of the Baltic countries as the RMS

    • Acting as the Marketing Authorization Holder

    • Marketing authorization maintenance (renewals, variations, Rx/OTC switch, MA transfer)

    • Management of product information (translations, editing, proofreading, etc.)

    • Management and approval of artworks and promotional materials

    • Local regulatory intelligence (regular updates on national regulatory legislation changes)

    • Notifications for Medical Devices and Food Supplements

    Reimbursement Services

    Our expert knowledge on the Baltic national reimbursement systems, mechanisms and processes, will help you navigate a route to access – from initial market access consultancy all the way up to obtaining reimbursement for medicinal products and medical devices. We can help you with:

    • Strategy and consulting on national requirements

    • Pharmacoeconomic analysis (cost minimization, cost effectiveness, cost utility)

    • Budget impact analysis

    • Localising global health economic models

    • Therapeutic value proposition

    • Preparation of application dossiers in line with local requirements

    • Submissions of applications and communication with national authorities (follow-up, preparation of answers to queries, liaison between the client and local authorities, etc.)

    • Price negotiations with national authorities

    Market Access Services

    We can help you understand the market potential of your current and potential future products in the Baltics, assess reimbursement landscape, evaluate market access opportunities and identify any identifying challenges or risks. Our market access support services include:

    • Local epidemiology data gathering

    • Intelligence on local treatment guidelines

    • KOL engagement

    • Payer interaction

    • Reimbursement pathways

    • Reimbursement and price negotiation support

    • Early access programs (EAP, CUP, NPP)

    DISCOVER HOW WE CAN HELP