Overview of Services

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

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

Field Medical Compliance & Effectiveness Program

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.

Detailed Reports

 

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

Core Practice Areas
Field Medical Compliance & Effectiveness Program

  • Field Medical Auditing
  • MSL Capability Design
  • Physician Education Strategy
  • Compliance Monitoring and Auditing
  • Field Medical (MSL)
    Content and Training Development
Presentation & Communication Skills Program

  • 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.
Medical Affairs Buildout

  • Operating Model Design
  • Process Design/Optimization
  • Performance Measurement/Reporting
  • KOL Identification & Assessment
  • Phase IIIB/IV Strategic Solutions
  • Scientific Platform Development
Publications Planning Services
  • Journals, abstracts, manuscript support
  • Systematic review, meta-analysis
  • Posters & Oral Presentations
Publication Planning Expertise & Tools

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

01

Publication planning tools  such as Datavision™

02
03

Referencing tools such as Reference  Manager® and Endnote®

04

Target journal selection tools such  as Elsevier Journal Finder

Expertise of Taber’s Medical Dictionary

and Stedman’s Medical Dictionary

05
06

Plagiarism free documents by  using iThenticate/PlagScan

07

Proof reading and editing  tools like Grammarly

Publication Planning Expertise & Tools
Clinical Research and Regulatory Writing

Regulatory Affairs

QC and QA of regulatory documents

  • 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.)

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

Pharmacovigilance Support

Case Processing

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

Literature Monitoring

Literature search for reports of adverse events (AEs)

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)

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

MEDICAL CONFERENCES AND ADVISORY BOARD SUPPORT

Identify an  unmet need in a  specified  therapeutic area

Prepare a pre-  conference/  meeting  presentation

Cover the  conference/  meeting

Competitive Intelligence

Develop a report  and/or consensus  after the meeting

EXPERTISE AND SKILLS FOR MEDICAL CONFERENCES AND ADVISORY BOARD SUPPORT

KOL coordination

Subject matter experts for major therapeutic areas

Medical writers available to travel globally

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

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

End-to-end publication support

HEOR and REAL WORLD EVIDENCE SERVICES

  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

EXPERTISE AND TOOLS FOR REAL WORLD EVIDENCE SOLUTIONS: PHARMACOECONOMIC REPORT
EXPERTISE AND TOOLS FOR REAL WORLD EVIDENCE SOLUTIONS: SYSTEMATIC REVIEW AND META-ANALYSIS
EXPERTISE AND TOOLS FOR REAL WORLD EVIDENCE SOLUTIONS: SYSTEMATIC REVIEW AND META-ANALYSIS

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.

 

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The AG Group can help Turn Science into a Compelling Story