- 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.
Clinical Project Management
- 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
Start up and Regulatory
- 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