Site Management Organisation
The success to your project depends on excellent team support, organisational skills, scientific knowledge, accurate budgeting, redaction and communication skills.
Working with CIDP ensures quality of service and efficiency through experienced and trained managers who are your main point of contact and single information provider for your project.
From study feasibility, protocol writing, data base design to site communication, supply handling, study follow up, reporting and database lock, CIDP’s project manager anticipates and manages the risks to ensure delivery of best results in due time.
With its global presence, CIDP has access to a network of investigators/specialists to manage your multi-centric clinical trials in different therapeutic areas.
Our team, in collaboration with dedicated professionals involved in scientific research, writes and revises reports/medical write-ups within the required deadline and design:
- Investigators’ Brochure
- Informed Consent Form
- Case Report Form
- Clinical Study Reports
- Periodic Safety Reports and Pharmacovigilance documents
- And any other documents that are needed
We strive for clarity, efficiency of presentation, and scientific accuracy. Our final goal is to produce concise and substantive clinical documents.
Ensure the choice of adequate investigational sites according to protocol and sponsor demands thanks to our team of qualified Trial Managers and CRAs.
- Site contact/communication
- Site negotiations
- Site budgeting
- Site audits
- Team training
- Site selection report
CIDP monitors are the key to high quality data, quick delivery and site support for your clinical trials while ensuring patient care, ethical principles, GCP, local requirements and protocol conformity.
Our CRAs are trained on particular therapeutic areas as well as protocol specific preparations.
- Site Initiation Visits (communication/ training/ audit/ report)
- Routine Monitoring Visits (communication/ ethics, GCP, protocolconformity/ Quality Control/ report)
- Close Out Visits (communication/ data clarification/ accountability, reconciliation/ report)
Clinical Trial Supplies
- Storage and distribution in accordance with Good Manufacturing Practice and Good Distribution Practice
- Inventory logs
- Labelling according to GMP and SOPs
- Return and destruction of product according to SOPs
Our Logistic services
- Custom and import management
- Extensive follow up (receipt; distribution; control of stock; regular inventories)
- Enable distribution locally or to other sites
- Close monitoring of storage conditions
- Destruction or return to sponsor
- Adapt to different clinical trials and provide tailor-made services