Provide strategic and evidence-based solution for investors, Biotech and pharmaceutical companies to make informed decision for investment.

1. Consultancy service

• Analysis of clinical data and clinical trial
  • Review and analyse clinical trial data to assess the rationale for the development.
  • Evaluate current clinical trials and protocols to identify the strengths and the areas for improvement.
  • Strategic recommendation
• Identification of unmet need areas and market potential
  • Analyse target disease area and standard of care to define the area of unmet medical need
  • Estimate the population size and market potential
• Competitive advantage and potential size of the population
  • Analyse the competitive landscape-existing and emerging therapies
  • Identify competitive advantages, opportunities and challenges
• Comprehensive risk assessment and mitigation plans
  • Identify clinical, regulatory and commercial risks.
  • Develop risk mitigation plans and contingency strategies

2. The standard consultancy report package

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

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).

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)