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  • Medical Affairs Effectiveness –
    • Field Medical Compliance & Effectiveness Program –
    • Presentation & Communication Skills Program –
    • Medical Affairs Design & Buildout –
  • Publications Planning Services –

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  • – Regulatory Affairs Support
  • – Pharmacovigilance Consulting
  • – Conference/Advisory Board Support
  • – Real World Evidence/HEOR Services
  • – Executive Level Coaching

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Field Visits with MSLs & HEOR Teams

 

Ensuring that field medical teams execute with flawless execution to maximize the effectiveness of interactions and build valuable thought leader partnerships.

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Detailed Reports

 

Provide detailed reports and recommendations to help drive long term strategy.

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Field Medical Compliance & Effectiveness Program

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  • Field Medical Auditing
  • MSL Capability Design
  • Physician Education Strategy
  • Compliance Monitoring and Auditing
  • Field Medical (MSL)
    Content and Training Development

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Presentation & Communication Skills Program

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  • Presentation skills for scientific material
  • Crisis Communications Training
  • Train leadership & leadership teams to respond to crisis situations
  • Create communication plans
  • Private coaching and consultation for individuals focused on leadership or a significant presentation.

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Medical Affairs Buildout

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  • Operating Model Design
  • Process Design/Optimization
  • Performance Measurement/Reporting
  • KOL Identification & Assessment
  • Phase IIIB/IV Strategic Solutions
  • Scientific Platform Development

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  • Journals, abstracts, manuscript support
  • Systematic review, meta-analysis
  • Posters & Oral Presentations

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Access and usage of medical journal  search engines and databases such as  PubMed, Ovid, EMBASE, TOXLINE etc

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Publication planning tools  such as Datavision™

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Referencing tools such as Reference  Manager® and Endnote®

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Target journal selection tools such  as Elsevier Journal Finder

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Expertise of Taber’s Medical Dictionary

and Stedman’s Medical Dictionary

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Plagiarism free documents by  using iThenticate/PlagScan

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” el_class=”planning-blocks” css=”.vc_custom_1508163300769{padding-bottom: 50px !important;}”][vc_column width=”1/2″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner width=”5/6″][/vc_column_inner][vc_column_inner width=”1/6″][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/2″][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner width=”1/6″][vc_raw_html el_class=”publication-steps”]MDc=[/vc_raw_html][/vc_column_inner][vc_column_inner width=”5/6″][vc_column_text]Proof reading and editing  tools like Grammarly[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1508216475949{padding-top: 50px !important;padding-bottom: 50px !important;background-color: #ffffff !important;}”][vc_column][vc_row_inner row_type=”row” type=”grid” text_align=”left” css_animation=””][vc_column_inner][vc_text_separator title=”Publication Planning Expertise & Tools” border=”no” el_class=”section-head”][/vc_column_inner][/vc_row_inner][vc_row_inner row_type=”row” type=”grid” text_align=”left” css_animation=””][vc_column_inner width=”1/4″]

Clinical Research and Regulatory Writing

Regulatory Affairs

QC and QA of regulatory documents

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  • Clinical Research Documents
  • Common Technical Document/Dossiers for
  • Clinical Trial Disclosures
  • Web Synopsis
  • Lay Summaries
  • Product Labelling
  • For submissions in various geographical regions  (IND, NDA, MAA, CTA, etc.)

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  • Protocol
  • CRF and ICF
  • Investigator’s Brochure
  • Clinical Study Reports

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Case Processing

Detailed case entry and follow-up Safety narrative writing  Individual Case Safety Reports (ICSRs)  Quality review and medical review

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Literature Monitoring

Literature search for reports of adverse events (AEs)[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=”” css=”.vc_custom_1508216817764{margin-top: 20px !important;}”][vc_column_inner width=”1/2″][vc_column_text]

Aggregate Reports

Risk Management REMS
Strategy (REMS) Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Adverse Drug Experience Report (PADER) Development Safety Update Report (PSUR/DSUR)

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Pharmacovigilance Consulting

Signal Detection, Evaluation, and Management
Pharmacovigilance database
SOP and Procedural Document Development Development of PV System Master File (PSMF)or Detailed Description of Pharmacovigilance System (DDPS) Pharmacovigilance trainings

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Identify an  unmet need in a  specified  therapeutic area

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Prepare a pre-  conference/  meeting  presentation

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Cover the  conference/  meeting

Competitive Intelligence

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Develop a report  and/or consensus  after the meeting

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KOL coordination

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Subject matter experts for major therapeutic areas

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Medical writers available to travel globally

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Expertise for clinical practice guidelines, consensus statement/recommendati ons, expert opinion etc.

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Guidelines compliant documents (such as GRADE recommend ations, RIGHT statement etc.)

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End-to-end publication support

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  1. End-to-end Support for Observational Studies, Registries,  Epidemiological and Retrospective studies: Protocol  development; Data analysis; Report writing: Publication support
  2. Economic Modelling and Health Economic Reports: Economic  developing; Health economic reports for  pharma/insurance/pricing agencies; Publication support
  3. Systematic Reviews and Meta-Analysis: Systematic literature  search; Data extraction and statistical analysis; Report writing:  Publication support

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Corporate & Executive Level Coaching

 

We help medical affairs organizations in pharma looking to invest in their people by focusing on presentation & communication style, conflict management, and setting goals.

We provide 1:1 coaching to clients around the world in the life sciences and work in particular with MD, PharmD, and PhD professionals.

 

Learn More[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”168″ img_size=”large” alignment=”center” qode_css_animation=””][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1508227399167{padding-top: 50px !important;padding-bottom: 50px !important;background-color: #ffffff !important;}”][vc_column][vc_row_inner row_type=”row” type=”grid” text_align=”left” css_animation=””][vc_column_inner][vc_text_separator title=”The AG Group can help Turn Science into a Compelling Story” border=”no” el_class=”section-head”][/vc_column_inner][/vc_row_inner][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner width=”1/2″][vc_single_image image=”172″ img_size=”large” alignment=”center” qode_css_animation=””][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”173″ img_size=”large” alignment=”center” qode_css_animation=””][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]