[vc_row type=”full_width_background” full_screen_row_position=”middle” bg_image=”6473″ bg_position=”center center” bg_repeat=”no-repeat” bg_color=”#ffffff” scene_position=”center” text_color=”light” text_align=”left” top_padding=”10%” bottom_padding=”15%” color_overlay=”#000000″ overlay_strength=”0.5″ enable_shape_divider=”true” shape_divider_color=”#ffffff” shape_divider_position=”bottom” shape_divider_height=”100″ bg_image_animation=”none” parallax_bg=”true” parallax_bg_speed=”fast” shape_type=”mountains”][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_row_inner equal_height=”yes” content_placement=”middle” column_margin=”default” text_align=”left”][vc_column_inner column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” width=”1/12″ tablet_width_inherit=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none” offset=”vc_hidden-sm vc_hidden-xs”][image_with_animation image_url=”6105″ alignment=”right” animation=”Fade In” border_radius=”none” box_shadow=”none” max_width=”50%” el_class=”header-icon”][/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” width=”1/2″ tablet_width_inherit=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none” enable_animation=”true” animation=”fade-in” offset=”vc_col-lg-6 vc_col-md-6 vc_col-xs-12″][vc_column_text css_animation=”fadeInUp” css=”.vc_custom_1567700055423{margin-bottom: 15px !important;}”]
Services
[/vc_column_text][split_line_heading]Pharmacovigilance
[/split_line_heading][/vc_column_inner][vc_column_inner column_padding=”padding-6-percent” column_padding_position=”bottom” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” width=”1/4″ tablet_width_inherit=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none” enable_animation=”true” animation=”fade-in-from-bottom” offset=”vc_col-xs-12″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” scene_position=”center” text_color=”dark” text_align=”left” id=”custom-sub-menu” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color=”rgba(0,0,0,0.01)” background_color_opacity=”1″ background_color_hover=”rgba(0,0,0,0.01)” background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” top_margin=”-150″ width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][page_submenu alignment=”center” sticky=”true”][page_link link_url=”/en/services/clinical-trial-services/” title=”Clinical Trial Services” id=”1763915520522-5″ tab_id=”1763915520522-6″][vc_column_text][/vc_column_text][/page_link][page_link link_url=”/en/services/regulatory-affairs-services/” title=”Regulatory Affairs Services” id=”1763915520565-6″ tab_id=”1763915520565-0″][vc_column_text][/vc_column_text][/page_link][page_link title=”Pharmacovigilance” id=”1763915520586-1″ link_url=”/en/services/pharmacovigilance/” tab_id=”1763915520587-10″][/page_link][page_link title=”Quality assurance” id=”1763915520609-7″ link_url=”/en/services/quality-assurance/” tab_id=”1763915520609-2″][/page_link][page_link title=”Medical Devices Support” id=”1763915520630-3″ link_url=”/en/services/medical-devices-support/” tab_id=”1763915520631-1″][/page_link][page_link title=”Other services” id=”1763915520652-1″ link_url=”/en/services/other-services/” tab_id=”1763915520652-6″][/page_link][page_link title=”GMP/GDP Services” id=”1763915523339-5″ tab_id=”1763915523341-6″ link_url=”https://www.clinres.si/en/services/gmp-and-gdp-services/”][/page_link][/page_submenu][/vc_column][/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” scene_position=”center” text_color=”dark” text_align=”left” top_padding=”7%” bottom_padding=”7%” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”padding-2-percent” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/2″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]Pharmacovigilance
[/vc_column_text][team_member image_url=”6785″ team_memeber_style=”meta_below” link_element=”none” color=”Accent-Color” name=”Jana Dragojevič, MPharm, PhD” job_position=”Head of Pharmacovigilance Department”][vc_column_text]Our Pharmacovigilance professionals offer PVG support, which can include global and/or local PV services.
[/vc_column_text][/vc_column][vc_column column_padding=”padding-2-percent” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/2″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][toggles style=”minimal”][toggle color=”Default” title=”PV for Marketed Products”][vc_column_text]Our services include:- Provision of qualified PV personnel (including QPPV, QPPV deputy, local PV contact, and medically qualified staff)
- Establishment and maintenance of PV systems
- Development and maintenance of Pharmacovigilance System Master Files (PSMF)
- Development and maintenance of Standard Operating Procedures (SOPs)
- Global and local literature monitoring
- Management of Individual Case Safety Reports (ICSRs)
- Generation and submission of aggregate safety reports
- Development and maintenance of Risk Management Plans (RMPs)
- Signal management
- Management of Direct Healthcare Professional Communications (DHPCs)
- Management of Risk Minimization Measures (RMMs)
- Monitoring of regulatory intelligence
- Electronic reporting of Individual Case Safety Reports (ICSRs)
- XEVMPD data management
- Audit and inspection readiness
- Pharmacovigilance training for both PV and non-PV personnel
- Management of pharmacovigilance agreements
We also offer pharmacovigilance support for veterinary medicinal products.[/vc_column_text][/toggle][toggle color=”Default” title=”PV for Clinical Trials”][vc_column_text]Clinres Farmacija offers complete drug safety development services during clinical trials including:
- Service of experienced professionals (responsible person for pharmacovigilance, and back-up),
- Registration with Eudravigilance Clinical Trial Module,
- Establishment of Standard Operating Procedures (SOPs) on clinical trial pharmacovigilance and other controlled quality documents,
- Management of cases and case processing (SAE),
- SAE medical review, MedDRA coding,
- Safety data reconciliation,
- Preparation and submission of Development Safety Update Reports,
- Preparation and submission of periodic SUSAR reports,
- Electronic reporting of Suspected Unexpected Serious Adverse Events (SUSARS),
- Reporting to Regulatory Authorities and Ethics Committees as appropriate,
- Supporting assessment of risk-benefit ratios throughout the trial and updating the Investigator Brochure as necessary,
- Developing of risk management plans in full compliance with regulations.
We offer dedicated phone and fax lines which enable you to personally contact a safety officer.[/vc_column_text][/toggle][/toggles][/vc_column][/vc_row]
