Pharmacovigilance

Through our in-house expertise and capabilities, we can provide pharmacovigilance services for your programs. We offer end-to-end solutions to help you navigate the complex landscape of drug safety across every stage of the clinical development journey, including:

Phase 1-4 Clinical Trials

Expanded Access Programs

Post-Trail Access Programs

Pharmacovigilance

Through our in-house expertise and capabilities, we can provide pharmacovigilance services for your programs. We offer end-to-end solutions to help you navigate the complex landscape of drug safety across every stage of the clinical development journey, including:

Pharmacovigilance

We offer end-to-end solutions to help you navigate the complex landscape of drug safety across every stage of the clinical development journey.

We integrate cutting-edge technology and deep regulatory knowledge to deliver timely and accurate insights to support your monitoring and reporting needs.

Our pharmacovigilance (PV) team works closely each Sponsor to understand their unique needs and design tailored safety management plans (SMPs) that are end-to-end and fully compliant:

Why work with WEP

  • Cost-Effective:

    We ensure full compliance and patient safety, while optimizing your operational efficiency and budget.

  • Regulatory Expertise:

    Our seasoned pharmacovigilance professionals understand the intricacies of local and international regulations.

  • Technology-Driven Solutions:

    Our tools and analytics streamline safety monitoring and reporting processes.

  • Focused on Sites:

    Our solutions are built to ensure reduced burden to site staff throughout the duration of your program.

Our Pharmacovigilance Services

If you would like to chat with our team about and learn more about WEP capabilities, then please complete the form to the left or contact us at:

Pharmacovigilance Services

Our Pharmacovigilance services help Sponsors manage safety reporting requirements across Expanded Access Programs, clinical trials, and post-approval access pathways with accuracy, consistency, and regulatory oversight.

Get in Touch

If you would like to chat with our team about and learn more about WEP capabilities, then please complete the form to the left or contact us at:

We typically respond in under 24 hours.

Need more information?

[fusion_builder_container admin_label=”” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”patients” hide_on_mobile=”medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”#ffffff” background_image=”” background_position=”left top” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”50px” padding_left=”” type=”legacy” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Through our in-house capabilities and partnerships with a select group of external companies, WEP Clinical can provide pharmacovigilance (PV) services for your programs. Whether you require basic event reporting or “full service” PV capabilities, WEP has the expertise to support your monitoring and reporting needs.

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”-20px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

BASIC ADVERSE EVENT REPORTING

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”50PX” margin_top=”-15px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_checklist icon=”fa-circle fas” iconcolor=”#f38832″ circle=”” circlecolor=”” size=”18px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]

Collect drug safety reports and perform an initial assessment of severity and urgency

[/fusion_li_item][fusion_li_item icon=””]Follow up with physicians and provide additional support[/fusion_li_item][fusion_li_item icon=””]Cascade completed reports to sponsors/manufacturers[/fusion_li_item][/fusion_checklist][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”-15px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

FULL SERVICE:

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”50PX” margin_top=”-15px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_checklist icon=”fa-circle fas” iconcolor=”#f38832″ circle=”” circlecolor=”” size=”18PX” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]

ADR case processing with medical review

[/fusion_li_item][fusion_li_item icon=””]

Reporting & submissions for drugs, vaccines, medical device, cosmetics & nutritionals

[/fusion_li_item][fusion_li_item icon=””]

Production, generation & submission of regulatory & aggregate reports (PBRERs, PADERs, SBRs, ASRs & DSURs)

[/fusion_li_item][fusion_li_item icon=””]

Drug safety literature review

[/fusion_li_item][fusion_li_item icon=””]

Provision and support with EU-QPPV services

[/fusion_li_item][fusion_li_item icon=””]

Signal detection- benefit-risk evaluation

[/fusion_li_item][fusion_li_item icon=””]

Risk management plans/ REMS

[/fusion_li_item][fusion_li_item icon=””]

Medical writing services

[/fusion_li_item][fusion_li_item icon=””]

Clinical trial drug safety protocol support

[/fusion_li_item][fusion_li_item icon=””]

Safety database build & validation

[/fusion_li_item][/fusion_checklist][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”10″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”20px” margin_bottom=”10px” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_button link=”mailto:[email protected]” text_transform=”” title=”” target=”_self” link_attributes=”” alignment=”left” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”email-link” id=”email-link” color=”custom” button_gradient_top_color=”rgba(245,136,33,0)” button_gradient_bottom_color=”rgba(245,136,33,0)” button_gradient_top_color_hover=”rgba(6,76,118,0)” button_gradient_bottom_color_hover=”rgba(6,76,118,0)” accent_color=”#ff9800″ accent_hover_color=”#064c76″ type=”” bevel_color=”” border_width=”” size=”xlarge” stretch=”default” icon=”fa-envelope fas” icon_position=”left” icon_divider=”no” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” border_radius=”0″ border_color=”#ff9800″ border_hover_color=”#064c76″][email protected][/fusion_button][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”patients” hide_on_mobile=”small-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”#ffffff” background_image=”” background_position=”left top” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”50px” padding_left=”” type=”legacy” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Through our in-house capabilities and partnerships with a select group of external companies, WEP Clinical can provide pharmacovigilance (PV) services for your programs. Whether you require basic event reporting or “full service” PV capabilities, WEP has the expertise to support your monitoring and reporting needs.

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”-20px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

BASIC ADVERSE EVENT REPORTING

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_left=”” border_radius_bottom_right=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”” box_shadow_spread=”” box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”10px” padding_bottom=”” padding_left=”10PX” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_checklist icon=”fa-circle fas” iconcolor=”#f38832″ circle=”” circlecolor=”” size=”18px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]

Collect drug safety reports and perform an initial assessment of severity and urgency

[/fusion_li_item][fusion_li_item icon=””]Follow up with physicians and provide additional support[/fusion_li_item][fusion_li_item icon=””]Cascade completed reports to sponsors/manufacturers[/fusion_li_item][/fusion_checklist][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”-15px” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

FULL SERVICE:

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_left=”” border_radius_bottom_right=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”” box_shadow_spread=”” box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”10px” padding_bottom=”” padding_left=”10PX” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_checklist icon=”fa-circle fas” iconcolor=”#f38832″ circle=”” circlecolor=”” size=”18PX” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]

ADR case processing with medical review

[/fusion_li_item][fusion_li_item icon=””]

Reporting & submissions for drugs, vaccines, medical device, cosmetics & nutritionals

[/fusion_li_item][fusion_li_item icon=””]

Production, generation & submission of regulatory & aggregate reports (PBRERs, PADERs, SBRs, ASRs & DSURs)

[/fusion_li_item][fusion_li_item icon=””]

Drug safety literature review

[/fusion_li_item][fusion_li_item icon=””]

Provision and support with EU-QPPV services

[/fusion_li_item][fusion_li_item icon=””]

Signal detection- benefit-risk evaluation

[/fusion_li_item][fusion_li_item icon=””]

Risk management plans/ REMS

[/fusion_li_item][fusion_li_item icon=””]

Medical writing services

[/fusion_li_item][fusion_li_item icon=””]

Clinical trial drug safety protocol support

[/fusion_li_item][fusion_li_item icon=””]

Safety database build & validation

[/fusion_li_item][/fusion_checklist][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”10″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”20px” margin_bottom=”10px” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_button link=”mailto:[email protected]” text_transform=”” title=”” target=”_self” link_attributes=”” alignment=”left” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”email-link” id=”email-link” color=”custom” button_gradient_top_color=”rgba(245,136,33,0)” button_gradient_bottom_color=”rgba(245,136,33,0)” button_gradient_top_color_hover=”rgba(6,76,118,0)” button_gradient_bottom_color_hover=”rgba(6,76,118,0)” accent_color=”#ff9800″ accent_hover_color=”#064c76″ type=”” bevel_color=”” border_width=”” size=”xlarge” stretch=”default” icon=”fa-envelope fas” icon_position=”left” icon_divider=”no” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” border_radius=”0″ border_color=”#ff9800″ border_hover_color=”#064c76″][email protected][/fusion_button][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”yes” menu_anchor=”” hide_on_mobile=”no” status=”published” publish_date=”” class=”” id=”” background_color=”#ededed” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”left” enable_mobile=”no” parallax_speed=”0.5″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”20px” padding_left=”” type=”legacy” flex_align_items=”stretch” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”yes” link=”” target=”_self” min_height=”” hide_on_mobile=”no” class=”” id=”” background_image_id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”2%” padding_right=”0px” padding_bottom=”2%” padding_left=”0px” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”down” animation_speed=”0.1″ animation_offset=”” last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]