1. CLINICAL TRIAL FEASIBILITY ASSESSMENT
We maintain our long-term relationships with the university medicinal centres for several years so we can recommend to our Clients which investigator can realize the requests of the project.
- Medical feasibility
- Clinical feasibility
- Logistical feasibility
- Regulatory feasibility
2. MEDICAL AFFAIRS
Medical Services and Consulting
- Medical Monitoring Plan, Safety Management Plan.
- Medical and scientific support for regulatory submission planning and preparation.
- Key opinion leader networking.
- Medical consultancy to the project team and investigators.
- Pharmacovigilance support.
- Prospective patient eligibility review.
- Analysis of reasons for screen failures.
- Laboratory data review.
- Medical imaging training and consultancy.
- Medical data review.
- Medical decisions regarding protocol compliance.
- Categorization of protocol deviations and violations and analyses of the trends.
Medical Writing Services
- Clinical study reports, protocols, manuscripts, newsletters, posters.
- Investigator Brochures.
- Informed Consent Forms.
- Patient diaries and patient information.
- Patient Safety Narratives.
- Regulatory documents.
- Regulatory responses and regulatory submissions.
- Annual safety reports and periodic safety update reports.
Pharmacovigilance (Safety Reporting)
Laboratory Support Services
3. CLINICAL DATA MANAGEMENT (CDM)
We assign International Project Manager who ensures a sponsor’s contact point for all trial-related questions.
- Electronic Data Capture (EDC) as per our clients’ solution needs.
- Development of Case Report Form (paper CRF/eCRF)
- Double-key data entry for paper CRF-based studies
- Monitoring and validating data through quality assessment and DBL.
- Database set-up.
Clinical biostatistics services
- Trial design.
- Sample size determination.
- Statistical analysis plan.
- Randomization management.
- Blind review.
- SAS tables, figures and listings.
- DSMB support.
Essential documents collection for submission to the Competent Authority and Ethics
Commission, contract negotiations including budgeting, costs optimizations, competitive
Visits, reviews of regulatory documents, training of investigators, resolution of queries,
preparation of Corrective and Preventive Action Plans.
Regular communication with the site.
4. REGULATORY AFFAIRS
Clinical Trial Application Services include:
- Formulation of customized submission strategy.
- Preparation and submission of clinical trial for regulatory approval.
- Maintenance of clinical trial authorizations.
- Organization of study supply logistics such as manipulation, storage, management of supply process, including obtaining import and export licenses.
- Liaison with national regulatory authorities and Ethics Committee.
- Translations, linguistic validation of Patient Reported Outcomes (PRO).
- Consulting on labelling requirements for Investigational Medicinal Products/clinical supplies.
- Procurement of insurance according to legal requirements.
- Safety Reporting.
- EU Legal Representation for our non-EU customers.