• Provide strategic and evidence-based solutions to Biotech and pharmaceutical companies to maximize clinical program success.

  1. Consultancy service
  • Clinical Development Plan
    • Clinical trial data analysis, identification of competitive advantage and rationale for development
    • Clinical development plan with clinical strategy, scenarios and clinical development path until regulatory approval.
    • Outline of key clinical trials, decision criteria and target product profile.
    • High-level key milestones and risk management
  • Clinical trial design and development of clinical documents
    • Design of clinical trials and development of synopsis and protocol
    • Review and optimization of existing protocols
    • Development of IB, ICF, DSUR and CSR.
  • Comprehensive risk assessment and mitigation plan of clinical trials
    • Identification of clinical, regulatory and operational risks.
    • Development of risk mitigation and contingency plans.
  2. Standard consultancy report package

Study Planning Phase:

• Develop or deliver clinical and medical input for clinical protocols, Investigator Brochures (IB), and Informed Consent Forms (ICF), ensuring adherence to Good Clinical Practice (GCP) and regulatory standards.
• Provide medical and safety oversight for the Safety Management Plan and Safety Committee Charters, monitor and evaluate trial participant safety, address adverse events, and prepare timely safety reports.
• Offer clinical and medical input to the Statistical Analysis Plan (SAP).
• Supply medical expertise for regulatory dossiers (IND Dossier and protocol amendments) and liaise with regulatory authorities on medical matters.
• Preselect countries, sites, and investigators, and contribute to the feasibility questionnaire.
• Develop or contribute to the Risk Management and Mitigation Plan by identifying and managing trial-related risks.

Study Set-Up Phase:

• Review site feasibility assessments and select suitable sites and investigators.
• Communicate and engage with Principal Investigators (PIs).
• Provide medical input for dossiers submitted to the Institutional Review Board (IRB) and address medical queries during IRB submission and review.
• Deliver protocol training and support during investigator meetings and site initiation visits.
• Conduct therapeutic area training for the internal study team.
• Contribute to the development of Case Report Forms (CRFs), including edit check specifications.
• Perform medical review of the study reference manual or pharmacy manual.
• Review and finalize the Medical Monitoring Plan, Safety Management Plan, IDMC charters, and independent review committee charters.

Study Conduct Phase:

• Medical monitoring and study oversight:
• Review eligibility packets.
• Address medical queries and escalate issues from study sites and the study team.
• Contribute to monitoring trial progress, including patient recruitment.
• Safety oversight:
• Assess Serious Adverse Events (SAEs) and edit safety narratives and queries.
• Ensure timely safety reporting, including expedited reports and Development Safety Update Reports (DSURs).
• Write the Analysis of Similar Events (AOSE) summary.
• Serve as the medical representative in Safety Monitoring Committee meetings (IDMC/SMC).
• Protocol compliance and deviation:
• Ensure adherence to the protocol, regulations, and ethical standards.
• Identify, address, and review protocol deviations, and contribute to Corrective and Preventive Actions (CAPA).
• Medical data review:
• Continuously review clinical trial data (medical records, lab results, SAEs) for accuracy and integrity.
• Perform medical coding review.

Data Analysis and Reporting Phase:

• Analyze, interpret, and report clinical trial data, and provide clinical and medical expertise to Clinical Study Reports (CSRs).
• Develop or contribute to scientific publications.
• Develop or contribute to Annual Development Safety Update Reports (DSURs) and updates to the Investigator Brochure (IB).

1. Clinical Trial Planning
   • Supporting the development of a briefing book for scientific advice
   • Leading the risk management process for a clinical trial
   • Providing input related to operational feasible into the clinical trial protocol (synopsis) and other clinical trial documents
   • Overseeing operational set-up
   • Performing a country feasibility study
   • Performing a site feasibility study
   • Performing a vendor selection (i.e. CROs, Labs, system provider, etc)
   • Supporting a vendor qualification, incl. reviewing SOPs
   • Negotiating vendor budgets and contracts
   • Negotiating site budgets and contracts
   • Preparing functional plans
   • Preparing the investigator’s brochure
   • Preparing the informed consent form
   • Arranging patient insurance
   • Arranging patient questionnaires
   • Supporting sponsor oversight for computerized system validations
   • Setting up a central lab
   • Setting up a drug depot and IMP courier
   • Ensuring appropriate training specifications and conduct
   Clinical Trial Conduct
   • Managing the clinical trial as clinical project lead
   • Overseeing participant recruitment
   • Conducting regular clinical trial team meetings
   • Overseeing vendor performance, incl. regular meetings
   • Initiating, and overseeing sites, incl. site meetings as required
   • Overseeing clinical trial performance (i.e. quality, timelines, resources, budget)
   • Overseeing clinical monitoring
   • Ensuring GCP compliance
   • Managing protocol and GCP deviation
   • Ensuring data governance (data capture and data cleaning)
   • Overseeing drug supply
   • Overseeing sample analyses
   • Ensuring communication between various internal and external stakeholders
   Clinical Trial Closeout
   • • Supporting data cleaning
     • Supporting final drug accountability/reconciliation
     • Overseeing site closures
     • Supporting data review meeting
     • Overseeing database lock
     • Performing final financial reconciliation
     • Supporting the preparation of clinical study report
     • Supporting TMF archiving

• End-to-End Project Management:

  Expertise in managing  projects from inception to completion, ensuring timely delivery and adherence to milestones, deliver and benefits

• Strategic Project Planning:

  Expertise in developing robust project plans, timelines, and budgets tailored to clinical research and product development needs.

• Risk Management and Mitigation:

  Proficient in identifying, assessing, and mitigating risks throughout the clinical development lifecycle to ensure project success.

• Cross-Functional Team Leadership:

  Skilled in leading and coordinating cross-functional teams, including clinical, regulatory, quality, and commercial experts.

• Stakeholder Communication and Engagement:

  Effective communicator with a proven track record of engaging and managing stakeholder expectations, from sponsors to regulatory bodies.

• Innovative Problem-Solving:

  Ability to address and resolve complex project challenges through innovative solutions and strategic thinking.

• Successful Product Launch Experience:

  Demonstrated success in bringing new products to market, from initial concept through clinical validation and commercialization, ensuring timely and effective market entry.

• Vendor and CRO Management:

  Extensive experience in selecting, managing, and collaborating with Contract Research Organizations (CROs) and vendors.

• Defining the organizational structure for your clinical research area
• Preparing job descriptions
• Hiring and onboarding GCP-experienced people
• Supporting and overseeing your clinical research team
• Defining a GCP-compliant strategy for your clinical research area
• Supporting the preparation of your clinical development plan and target product profile
• Overseeing your clinical research activities (i.e. quality)
• Planning timelines, resources, and budget
• Controlling the clinical research budget
• Providing vendor governance (covering all clinical trials)
• Defining GCP processes (SOP framework)
• Preparing templates for GCP documentation
• Providing training (on-site and online training sessions)

Strategic Medical Planning

• • • Develop competitive advantage and differentiation through clinical data, disease area, and competitive intelligence analysis.
    • Formulate medical strategies and plans for pre-launch and launch phases and post-launch activities.
    • Perform data gap analysis and evidence generation planning.
  • Scientific Exchange and Communication
    • Facilitate the exchange of scientific and medical information between companies and healthcare professionals (HCPs).
    • Conduct advisory board meetings- organize, chair, co-chair advisory board meetings.
    • Address medical inquiries, present data at conferences, and engage in research discussions.
  • Clinical Research Support
    • Connect the clinical team with new sites and good potential principal investigators
  • Medical Education and Training
    • Develop and deliver educational programs for internal teams (e.g., sales, marketing) and external stakeholders (e.g., HCPs).
    • Ongoing updates with update scientific information and competitive landscapes
    • Ensure dissemination of accurate, non-bias and updated information on products and therapeutic areas.
  • Medical Science Liaison (MSL) Optimization
    • Enhance MSL teams for better engagement with HCPs through digital and remote communication.
    • Build and maintain relationships with key opinion leaders (KOLs) to gather critical insights.
    • Training and Development: Offer training programs for MSLs and other medical affairs professionals to enhance their skills and stay updated with industry trends and regulations.
  • Post-Marketing Surveillance
    • Monitor the safety and efficacy of products post-market.
    • Conduct post-marketing studies, analyze real-world data, and manage risk-benefit profiles.
    • Write up and publish post – marketing studies in medical journal and present it in international conferences.
  • Study Design and Execution
    • Design and execute clinical studies to address data gaps and support product claims.
    • Ensure thorough and compliant study execution to generate necessary evidence.
  • Real-World Evidence (RWE) and Data Analytics
    • Leveraging real-world data to generate evidence supporting medical and commercial decision-making.
    • Demonstrating the value and effectiveness of products.
  • Regulatory and Compliance Support
    • Ensure compliance with regulatory requirements and industry standards.
    • Prepare regulatory submissions, manage adverse event reporting, and ensure promotional materials are scientifically accurate and compliant.
  • Patient Engagement and Support
    • Improve patient outcomes through enhanced engagement and support using innovative technologies and data-driven insights.
    • Engage patient advocate groups to have medical education with patients and their caregivers.
    • Provide medical expertise in clinical trials, ensuring protocol adherence and aiding patient recruitment and retention strategies.