Medical Information
QbD offers a set of Medical Information solutions, a distinctive offering in the Health Sciences Consulting sector.
With an emphasis on regulatory compliance as a revenue-generating activity, our comprehensive approach integrates scientific methodologies, proprietary tools and a team of experts in pharmacovigilance, biopharmacovigilance and medical device surveillance. Effective regulatory compliance and valuable information improve the marketing of products and the confidence of prescribers and patients.
Our Medical Information Solutions
Scientific Service
Critical reading and interpretation of information, specializing in Evidence-Based Medicine Medical Writing. Expert technicians in specific therapeutic areas ensure compliance with local policies and effective document management.
Standard letters, Q&A
- Scientific response letter to unsolicited question for healthcare professionals and providers.
- Evidence-Based Medicine: Adverse events, drug-dosing and administration, therapeutic use, special patients, risks, clinical overview data, RWE data.Â
- Create and update databases with all the letters and enquiries.
- Preparation of standard scientific letters and Q&A at international and local levels.
Medical Writing
Coordinate, write, edit and review of medical and scientific text.
Medical and Scientific Writing: scientific articles, clinical trials, product use letters, clinical overview, pathology and product report or overview, GINF.
Regulatory Medical Writing: documentation related to product development and authority’s product registry, Dossier.
Proposal Writer: funding and resources project proposal. · Medical Communication: communication review (oral communication/poster) and follow-up of medical and scientific congress, reports, scientific communication, website content, etc.
Promotional and Non-Promotional Actions Review & Compliance
Quality Control of the procedures. Professionals Certified with Veeva Vault. Therapeutic area specialist technicians. Promotional and Non-Promotional Materials: Marketing Materials.
- Translation and Review of promotional and non-promotional materials: marketing and sales materials, scientific meeting materials (abstracts, slides…), scientific training documents, Patients Brochure, Healthcare Professional Brochure (Nurses, Pharmacist, Physicians, etc.).
- Translation and Review of promotional and non-promotional materials: Launches, Scientific Meetings and Congresses, Advisory Boards.
- Scientific-medical content and compliance support. Scientific Review.
- Ensure the scientific quality and accuracy of the provided data in relation to the scientific source of information.
- Regulatory Review & Compliance.
- Material review, adapt and comply with each Local Policy Guidelines: EU Countries, Spain and Spanish Regions.
Key Opinion Leaders Validation
- Validate Key Opinion Leaders (KOLs) through rigorous analysis of their scientific background.
- Identify influential healthcare professionals for optimized Marketing & Sales impact.
- Strategically target specialists and key primary care physicians.
- Enhance overall effectiveness in the health sector.
Safety (PV, MD, Vet. Cosmetics, etc) and Scientific Literature Monitoring. Scientific Alerts. Literature Searches
Vigilance
- Monitoring about product & pathology.
- Vigilance literature searches: Pharmacovigilance, Cosmetovigilance, Medical devices & Veterinary.
- Regulatory Intelligence: Pharmacovigilance, Cosmetovigilance, Medical devices & Veterinary.Â
- Audit Support.
- Monitoring of National and International Authorities, Patients association websites,Healthcare Profesionals and association websites, Pharmaceutical bulletins and newspapers, Regulatory/Legal update, Healthcare Professional & Pharmaceutica Industry associations.
Search
- Scientific databases (PubMed, Embase, Cochrane, etc.).
- Create a search strategy to receive articles of interest about products, pathology and Pharmaceutical Industry content aimed at all types of healthcare and pharmaceutical industry professionals.
Scientific Alerts
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Scientific Literature Metrics.
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Communicate to Healthcare and Pharmaceutical Industry professionals, the most important points of the Vigilance & Search results.
Scientific Database Training
Medical Information searches activities focused on Evidence-Based Medicine.Â
Train Medical Information, Regulatory Affairs, and Pharmacovigilance Areas to perform database searches.Â
Advanced Searches: PubMed, Eudravigilance, Embase, Cochrane, etc
Medical Writing
Critical reading and interpretation of the information. Evidence-Based Medicine Medical Writing. Therapeutic area specialist technicians. Compliance with Local Policy. Document management.
Standard letters, Q&A
- Scientific response letter to unsolicited question for healthcare professionals and providers.
- Evidence-Based Medicine: Adverse events, drug-dosing and administration, therapeutic use, special patients, risks, clinical overview data, RWE data.
- Create and update databases with all the letters and enquiries.
- Preparation of standard scientific letters and Q&A at international and local levels.
Medical Writing
- Coordinate, write, edit and review of medical and scientific text.
- Medical and Scientific Writing: scientific articles, clinical trials, product use letters, clinical overview, pathology and product report or overview, GINF.Â
- Regulatory Medical Writing: documentation related to product development and authority’s product registry, Dossier. · Proposal Writer: funding and resources project proposal.
- Medical Communication: communication review (oral communication/poster) and follow-up of medical and scientific congress, reports, scientific communication, website content, etc.
Dossier Clinical Overview Writing: Module 5
- Analyze and interpret clinical data in the Common Technical Document, including relevant information.
- Specially for regulatory agencies reviewing the clinical section of marketing applications.
- Serves as a reference for regulatory staff reviewing other sections of the marketing application.
- Emphasize on presenting strengths and limitations of the development program for a comprehensive understanding.
Scientific Literature Metrics-Bibliometrics.
We provide full-text articles for diverse purposes, ensuring copyright compliance. Additionally, our bibliographic metrics service supports decision-making in content selection, trend evaluation, and improvement point identification.
Scientific Articles
- Creation of databases about products and pathology articles.Â
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- Document Management.Â
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- Article recovery.
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- Cedro Copyright Licence.
Scientific alerts and periodic content digest
- Bibliometric screening and monitoring of the information.
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- Content digest to provide updated, critical and objective information of the latest news and scientific publications.
Call Center
- On-demand services by specialized technicians, available 24/7.
- Medical Information Call Center for patient inquiries, adhering to data protection laws.
- Addressing health professionals’ phone queries on products, pathology, and pharmacovigilance.
- Comprehensive information collection and analysis for regulatory and quality impact.
- Central point of contact for resolving queries and doubts about various products.
Why QbD Group?
The Medical Information team of QbD Group, comprised of health professionals, brings a wealth of expertise to ensure the utmost scientific rigor in crafting our services. Possessing a CEDRO license and extensive proficiency in scientific databases such as PubMed, Cochrane, Embase, Medline, IME, and more, we are equipped to deliver comprehensive and meticulously researched solutions.
With more than 10 years providing life sciences consulting services and more than 450 experts. Our experience ensures optimal compliance with national and international PV regulations.Â
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10+ years of experience
Full life cycle support
Global presence
Best Managed Company
Contact us
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