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Medical Reporting & Analytics

Azante

Welcome to Azante

     Welcome to Azante Medical Reporting & Analytics, your trusted partner for top-tier medical regulatory writing and scientific communication. Founded by Dr. Azza Gramoun, Azante specializes in providing professional medical and scientific writing services bespoke to the medical device regulatory domain.

      Our comprehensive services encompass regulatory strategy development, clinical data analysis, and documentation compilation for CE marking, including Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans, State of the Art (SOTA) literature reviews, and Systematic Literature Reviews (SLRs). As clinical data experts, Azante excels in creating customized strategies to maximize the potential of your data, ensuring regulatory compliance and optimal outcomes. Azante Medical Reporting & Analytics, a technology enthusiast, leverages advanced digital solutions to enhance efficiency and accuracy and ensure client satisfaction at every step of our collaboration.  

     Contact me today to discuss how Azante can support your medical writing and regulatory consulting needs.

Transforming Data into Regulatory Precision

SERVICES

Regulatory Writing and Consulting

Honing an extensive medical writing and regulatory writing skillsets, Azante provides expert writing services in:  

  • Clinical Evaluation: Comprehensive support for Clinical Evaluation Plan (CEP) and Report (CER), State of the Art (SOTA), Literature Search Review Plan (LSRP) and Report (LSRR).

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  • Clinical Evaluation: Comprehensive support for Clinical Evaluation Plan (CEP) and Report (CER), State of the Art (SOTA), Literature Search Review Plan (LSRP) and Report (LSRR).

  • Clinical Development: Crafting Clinical Investigation Plan (CIP) and Report (CIR), Investigator’s Brochure (IB), and Synopses.

  • Post-Market Clinical Follow-up: Assistance with PMCF plans and reports.

  • Patient and Healthcare Professional Documents: Creation of Summary of Safety and Clinical Performance (SSCP), narratives, and Instructions for Use (IFU).

  • Technical Documentation: Compilation of comprehensive technical documents.


Regulatory Writing and Consulting

Scientific Communication

With 15+ years of scientific writing experience, we can tackle projects of all scales:

 

  • Publication Planning: Strategic plan development and management.

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  • Publication Planning: Strategic plan development and management.

  • Manuscript Preparation: Drafting primary and secondary manuscripts.

  • Journal Review Revision: Thorough review and revision for submission.

  • Abstracts, Posters, Presentations: Creation of impactful materials.

  • Structural Editing, Quality Control: Detailed quality assurance.



Scientific Communication

Technical
Writing

Our technical writing services include:

 

  • User Manuals and Guides: Clear documentation for product usage.

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  • User Manuals and Guides: Clear documentation for product usage.

  • Technical Specifications: Detailed descriptions of product features.

  • Standard Operating Procedures (SOPs): Development of standardized procedures.

  • User Manuals and Guides: Clear documentation for product usage.



Technical Writing

Scientific Copy Creation and Editing

Our expertise in scientific copywriting and editing extends to:

 

  • Copy Creation: Crafting engaging scientific content.

  • Copy Editing: Thorough editing for clarity and coherence.

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  • Copy Creation: Crafting engaging scientific content.

  • Copy Editing: Thorough editing for clarity and coherence.

  • Content Optimization: Fine-tuning for enhanced readability and impact.

Structural Editing & Quality Control

Alongside our editing and quality assurance services, we offer:

 

  • Thorough Reviews: Ensuring accuracy, clarity, and consistency.

  • Standardized Style: Implementing consistent formatting and citations.

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  • Thorough Reviews: Ensuring accuracy, clarity, and consistency.

  • Standardized Style: Implementing consistent formatting and citations.

  • Language Refinement: Enhancing readability and coherence.

CAREER PATH

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Undergraduate Studies

Bachelor of Oral and Dental Medicine (Grande distinction with honours), Cairo University

Graduate Studies

Doctorate of Philosophy in Molecular Bone Biology, University of Toronto

Clinical Research Coordinator

Developing a study protocol for chair-side testing of antimicrobial resistance, DAAD

Postdoctoral Fellow

Monitoring arthritis using Nanoparticles as MRI contrast agent, University of Geneva

Lead Medical Writer

Conducting SLRs and clinical evaluations for medical devices, Giotto.ai

CERTIFICATIONS & PROFESSIONAL DEVELOPMENT

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Logo Azante
Logo Azante

November 2023

Certificate

BSI Clinical evaluation for medical devices training and exam certificate

Workshops

May 2022- Present

EMWA Professional Development Program (EPDP)

1. Writing the State of the Art for Medical Devices according to MDR 2017/745
2. Writing a Clinical Evaluation Plan for Medical Devices
3. Post-market Clinical Follow-up (PMCF) for Medical Devices
4. Writing Clinical Evaluation Report for Medical Devices
5. Literature Reviews for Medical Devices
6. How to Compile the Summary of Safety and Clinical Performance (SSCP) for Medical Devices

7. Critical Appraisal of Medical Literature

8. Statistical Testing

9. Introduction to Pharmacovigilance Writing

November 2021

Workshops

Gathering Clinical Evidence for Medical Devices Training Educo Life Sciences, (3x 3-hour workshops)

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Logo Azante
Logo Azante

Clinical Research Certificate

October 2020-Feb 2021

4-month full-time program Pharmaakademie, Germany 

  1. Development and licensing of pharmaceutical products and medical devices

  2. Clinical trial overview (phases, design, protocol, monitoring and essential documents) as well as data management in clinical research (CTMS, EDC)

  3. Pharmacovigilance in drug/device development (AE, SAE, SUSAR)

  4. Human subject protection and regulatory oversight (AMG, MPG, ICH-GCP, EU MDR)

  5. Audits & inspections: ensuring clinical research quality

January 2016-June 2020

Certificate

Volkshochschule Bonn, Germany    

Completed (B1) and (B2) level German certificates (Certificates obtained in June 2017 and 2020) 

EXPERTISE

Escribiendo en una computadora portátil

Oral and Dental Medicine

Molecular Cell Biology

Dental Implants

Orthopedics
(Knee and Hip Replacement)

Spinal Cord Stimulation
(SCS)

Clear Aligners

Arthritic Bone Diseases

Advanced Diagnostic Imaging Modalities (MRI and CT)

Health Technology Assessment (HTA)

Biomakers and In vitro Assays

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Medical Reporting & Analytics

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