Other clinical activities
Data Management and Statistics Coordination
We ensure adequate liaison with key stakeholders within different activities that are typically outsourced, such as Core Laboratories, database designers, database management, statisticians…
We can include the treatment of data-management and statistics in our global budget proposal.
We ensure full management of CEC (Clinical Event Committee) and DSMB (Data Safety Monitoring Board)
CRF Design Coordination
We closely work with independent paperCRF or eCRF designers and ensure deep understanding of sponsor needs in terms of data collection. Ensuring thorough, per protocol, data collection needs to be coupled with effective understanding by sites of the data requested, and realistic data collection translation into a CRF.
We ensure document writing and/or review, from Clinical Investigational Plans to study clinical reports, CRF design, IBs, SOPs, presentations/publications, study reports…etc
Transitional Management & Interim Clinical Team management
We ensure management of your clinical trials and clinical teams according to your needs. Transitional management of your EU clinical teams can be handled by our VP-level, industry experienced General Manager, whereas interim study management can be taken over at short notice by our clinical staff. This meets the needs of any emergency, ranging from staff departure, pregnancy, illiness, or team reorganization.
Clinical regulatory expertise
Our awareness of the changing regulatory rules and needs for continuous enhancement of GCP standards helps Sponsors moving into change without undue loss of time and effort. We have a track record of facilitating awareness of clinical regulations for remote locations and ‘young’ Sponsors.
We provide, through interaction with specialist expert advice, health economics analysis and guidance on reimbursement (specific to each European country). We act as facilitators and single point of interaction towards Sponsors.
Executive Committee Management
We can manage your Executive Committee meetings, bringing both the scientific assistance and the needed smoothness and flexibility to your KOL members in order to relieve you from difficult discussions with you key stakeholders whilst achieving strict ethical and scientific goals.
CA & NB Liaison
We ensure liaison with all European Competent Authorities and meet them, with or without the Sponsor’s presence, as needed.
Emergency salvage is quite frequent in clinical activities. If a non-conformity is detected and needs to be immediately remedied, if a situation becomes difficult to manage directly between a Sponsor and a clinical site, if a situation needs immediate care and the Sponsor has no assigned staff for this task, we can step in and help you resolve the issue.
We can perform either directly or through an independent auditor that we contract, any and all clinical research audit activities (organizational, procedural, site and study audits). We can also prepare your sites to competent authority inspections or Sponsor audits, through audit preparation site visits or mock inspections/audits.