Project Management
- study design generation & core study document creation
- study planning set up & management (project management, risk management, change management, recruitment, & communication plans)
- site contract negotiations & set up
- team management (train, support & manage project dedicated teams)
- study completion according to the agreed deliverables budget & timelines
- management access to PRO/COA (patient reporting outcomes/clinical outcome assessments) until licencing (selection by the domains they measure as well as the populations and the therapeutic areas they cover, availability of translations, copyrights, conditions of use, measurement properties, scoring information, time required for completion, validation)
Clinical Monitoring
- recruitment and selection of study sites
- study files set up and maintenance
- in-house and on-site management and monitoring
- investigator & monitor meeting organization, conduct and participation
- SAE and SUSAR reporting
- investigators’ payment & clinical grant management
- remote monitoring
Safety & Pharmacovigilance
- safety review of CRFs in house by qualified personnel
- full reporting of SAEs according to Sponsor’s safety reporting SOPs and systems
- timely follow-up of all SAEs in close collaboration with all related parties
- AE/SAE (s) Reconciliation
Complete pharmacovigilance services offered via established partner which include:
- provision of responsible person for pharmacovigilance
- Eudravigilance registration & Safety reporting
- assessment and medical review of serious adverse events
- Safety Update Reports to Authorities
- 24hr Safety Contact Person
Data Management
- protocol and (e) CRF development
- database set-up & programming
- creation of annotated CRF
- Query management
- Medical data Coding
- safety review of CRFs
- single/double data entry
- creation of DMPs( Data Management Plans) data validation checks,
creation of validation programs and DCFs generation - SAE reconciliation
- Database QC
Biostatistics
- statistical input write up in study protocols including sample size calculation
- randomization schedule creation
- creation of SAP (Statistical Analysis Plan)
- statistical programming
- development of statistical tables, figures and listings
- interim analysis
- statistical or integrated report preparation
- clinical study report preparation
- creation of CDISC compliant databases
Market Research
- questionnaires’ development
- coordination of questionnaires’ distribution/collection
- organization & conduct of focus groups
- data entry and statistical analysis
- interpretation of results (report)
- presentation custom made to clients’ requirements
- advisory boards
Medical Writing
- scientific & clinical documents (protocol synopses/full protocols, patients’ informed consent & case report forms) preparation & writing
- abstract, poster presentation and manuscript preparation & writing
- clinical study report input
- literature search & review conduct, as appropriate for publication/document development
- training materials preparation
- clinical manuals preparation
Medical/Scientific Translations
- translation of medical and scientific texts, including protocols, patients’ informed consent forms journals, articles, abstracts/posters, scientific/clinical manuals, contracts & training materials
- proofreading and certificate of translation or/and backtranslation by a certified translator are available upon request
Additional Services
- feasibility: Identification and Selection of study sites
- regulatory affairs: support in strategy set up, IRB/IEC & RA submissions, site contract management
- vendor management: identification, selections & management of vendors
- clinical & administrative: Assistance: provision of clerical & administrative support in house, at the client, at the site
- quality assurance: study/site/TMF/vendor audits, SOP development
- training: detailed & comprehensive clinical research training programme, ICH-GCP training, , investigator clinical research & study specific training programs
