Medical Affairs and Clinical Research

With healthcare ecosystems changing rapidly, the pharmaceutical industry needs to adapt to the current and emerging healthcare needs. Now, more than ever, true focus on providing value to the patients and stakeholders is key to organize and provide care. For medical teams, this change represents a big opportunity to position themselves as partners, co-creating solutions to improve patient outcomes and experience of care.

Additionally, with the fast pace of scientific advances, complex therapies are  transforming treatment paradigms with medical teams playing a central role in  nowledge transfer to external stakeholders and devising evidence generation  strategies. Medical teams need to ensure all healthcare stakeholders understand the impact of these innovations for patients and the importance of timely access.

Finally, digital channels are becoming a prominent way of communication and medical
teams need to adapt to the emerging stakeholder needs, of accessing information when and where is needed.

HOW FINOMENA HELPS MEDICAL AFFAIRS LEADERS MANAGE THIS TRANSFORMATION

Every journey starts with a first step. The time is now for Medical Affairs leaders to initiate the journey and guide their organization successfully through their medical transformation.

Only with a compelling vision for the future, a clear plan and strong change  management this journey will be a success. We support Medical Affairs departments and leaders to achieve their business transformation while focusing on our common goals:

Drive Medical Affairs and clinical research strategy

Every successful medical strategy needs to starts with a compelling and clear vision. We help medical teams define their vision, strategy and the roadmap to achieve their results.
Personalize medical engagement: With the availability and time of stakeholders becoming more and more limited, Medical teams need to provide valuable content through the right communication channels. We help teams develop engaging narratives to share the value of their products and the right strategy and tools to tailor and personalize communication with stakeholders.

Accelerate medical organization

Finomena helps medical teams improve their operational efficiency and define fit-for-purpose performance management approaches to demonstrate their value to the rest of the organization.

Step-up people and leadership to drive change

People are at the core of the success of a team.
We help teams and leaders grow their capabilities and become better professionals, with change management as a key foundation of any transformation project.

SOLUTIONS WE PROVIDE

01

Medical affairs

  • Advisory Board
  • Standalone Meetings
  • Conferences & Symposia
  • Medical Slides building
  • Medical Training
  • Preceptorships
  • CMEs
02

Patient Safety

  • Outsourcing Qualified Person of Pharmacovigilance (QPPV)
  • Periodic Safety Update Reports (PSURs)
  • Ad hoc Analysis
  • Risk Management Plan (RMP)
  • Pharmacovigilance Database outsourcing
  • Processing Individual Case Safety Report (ICSR)
  • Periodic benefit-risk evaluation reports (PBRER)
03

Clinical Operation

  • Regulatory Submissions
  • Investigators Selection
  • Conducting General Feasibility Assessments and site selection
  • Investigator Brochure Development
  • Investigator Meeting Management
  • Clinical Trial Monitoring
  • Adverse event/ SAE Reporting
04

Medical writing

  • Clinical Study Protocol
  • Informed Consent Form (ICF)
  • ICH-E3 Compliant Clinical Study Report (CSR)
  • Integrated Summary of Safety & Efficacy Reports
  • Publications (Manuscript, Editing & Submission)
  • Slide Deck & Posters Development
  • Advisory Board Meetings; Minutes and Reporting
05

Biostatistics

  • Study Design including SAP
  • Statistical Inputs in Study
  • Protocol
  • ICH-E9 Compliant Analysis & Reporting: SAR
  • Interim Analysis
  • Post-Hoc & Exploratory Analyses
  • Sample Size Calculations/ Justifications
06

Clinical data management

  • Electronic Data Capture (EDC) 
  • SDTM Compliant CRF Design, Annotation & Completion Guidelines
  • Data Management Planning (DMP)
  • Data Validation Plan (DVP)
  • Database Design &Validation
  • Edit Checks Creation &Validation
  • Safety Reconciliation
07

Medical information

  • Answering physician medical queries with an evidence-based medicine
  • Design and formulate Observation and interventional studies
  • Pharmacoeconomics models 
  • Systematics reviews and meta-analysis
  • Patient education and awareness
  • Enhance Real world evidence with Machine learning algorisms
  • Reduce medical errors with personalized medicine

Ready to work with us?

Start working with us today and get a wonderfull experience

Why Finomena