services
MEDICAL ADVICECLINICAL PROJECT MANAGEMENTSTART UP AND REGULATORYSITE CONTRACTINGQUALITY MANAGEMENT
Dariusz Stencel MD, PhD
MEDICAL ADVISOR

Magdalena Jaskłowska-Englisz MSc., PhD
CLINICAL PROJECT MANAGEMENT ADVISOR

Bartek Jarosz
SITE CONTRACTS & START UP ADVISOR

Bartek Jarosz
SITE CONTRACTS & START UP ADVISOR

Agnieszka Żmuda-Deleżuch MSc
QUALITY MANAGEMENT EXPERT

Maciej Balas MD
MEDICAL ADVISOR

Paweł Kaczorowski MD
CEO, MEDICAL & PROJECT MANAGEMENT ADVISOR

   
Paweł Kaczorowski MD
CEO, MEDICAL & PROJECT MANAGEMENT ADVISOR

    

 

  • Scope of services:
    • Protocol review and medical support to protocol writers.
    • Medical input to key study documents (Patient Information / Informed Consent, Clinical/Project Management Plan, Study Protocol, Clinical Study Report, etc.).
    • CRF and Data Validation Plan review.
    • Medical Monitoring Plan development.
    • Medical review of AE/SAEs, aggregate data, patient profiles.
    • Medical assessments and narratives for AE/SAEs.
    • Coding review.
    • Input into steering committees and investigator meetings.
    • Indication/project specific/pharmacovigilance training and workshops.
    • Advice on product development plans and their execution.
    • Clinical Study Report and other medical data presentations. (posters, conference abstracts, etc.).
    • Medical writing.
    • Polish/English medical text translations.
    • Board certified specialist’s consultation available in selected indications for specific activities like protocol development, site selection, patient recruitment, etc.
    • We recommend two Medical Advisors per project to ensure highest security level of contracted services.
  • Project Management for all types of clinical trials/programs and observational studies
  • Clinical & Project Management procedure (SOP) preparation/review
  • Clinical Project Management (CPM) oversight
  • Project Management Plan preparation and review<
    • Monitoring, Risk, Quality, Communication Plans
    • Implementation of Evidence Based Medicine (EBM) criteria: blinding, lost to follow up management
  • Recruitment strategies
  • GCP Training – new EU regulation No 536/2014
  • Delivering process improvement
  • Coordination of feasibility and site selection activities
  • Provision of information on documents needed for submission in the involved countries
  • Assembling ”core dossier”, i.e. Study Protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), Delegation Letters, Manufacturing Authorization, etc.
  • Preparation of core EUDRACT XML file and study specific cover letter to Health Authority (HA)/ Ethics Committee (EC)
  • Coordination of clinical trial submissions and follow up with regulatory bodies and ECs to obtain approvals
  • Support in the contracting process with study sites
  • Preparation and guidance for Investigational Product (IP) Release Process
  • Regulatory training for CRAs or country HA contacts regarding the protocol, study documents and local requirements
  • Assessment of existing processes and procedures (SOPs) describing preparation, negotiation and execution of site agreements. Improvements in efficiency, speed and cost control. Drafting new processes from scratch.
  • Evaluation of contract templates against the latest industry trends and compatibility with the CRO/Sponsor’s key interests. Consultancy to prepare new templates.
  • Contract related training programs designed for study teams as well as individuals (negotiators, team leads, project managers). Hard skills – understanding of contract content. Soft skills – negotiation skills and assessment of knowledge competency gaps.
  • Assessment of processes overlapping between contracting and site payments. Gap analysis.
  • Evaluation of Key Performance Indicators (KPIs) and contracting cycle times, including recommendations for improvement.
  • Regulatory Inspection Support
    • Investigational sites preparation and training
    • Sponsor/CRO preparation and training
    • Regulatory Inspection Readiness strategy
  • Corrective Action and Preventive Action (CAPA) Plans
    • CAPA plan development
    • CAPA tasks coordination
    • CAPA effectiveness review
  • Support with the design of training programs and development/review of materials
    • Regulatory requirements, Good Clinical Practice, SOPs
    • Monitoring activities (i.e. SDV, SDR, ICF)
  • Development and / or implementation of vendor e.g. CRO oversight strategy
  • Quality Advisory on regulatory and GCP compliance
  • Processes and quality systems
    • Process mapping, gap analysis, SOP development, process compliance assessment, advisory on quality improvement measures and solutions
  • Clinical Quality Plan Development
  • Risk management