4Clinics is a Contract Research Organization (CRO) providing Data management, Safety, Biostatistics, Scientific Writing, Regulatory Affairs and Clinical Operations services for clinical and epidemiological studies with a particular expertise in vaccines, immunology and cell therapy. Furthermore. 4Clinics provides fully integrated and stand-alone services in SAS programming, Scientific Communication, Clinical Project Management and Pharmacovigilance.
4Clinics provides comprehensive clinical expertise to meet the needs of its clients. It has long experience of clinical trials, allied methodologies and healthcare, and takes pride in giving its clients satisfaction.
4Clinics benefits from the Research Tax Credit agreement (“Credit Impôt Recherche”).
|Key people||CEO; Xavier Ghyssens (M.Sc.)|
|Number of employees||180 employees|
- 1 History
- 2 SERVICES:
- 3 Controversies
- 4 Top 5 Recent Tweets
- 5 Top 5 Recent News Headlines
- 6 Top 5 Lifetime Tweets
- 7 Top 5 Lifetime News Headlines
- 8 References
The Company was founded in 1998. The story started with Xavier Ghyssens, the current CEO of the company. After he obtained a Masters Degree in Physics, he subsequently went on to obtain a Degree in Finance from the Université Catholique de Louvain(UCL). He founded All4it Groupe in 1998. He had a vision: all companies have a hidden wealth of information in their files – in fact, their own “goldmine” of information - which is not exploited to the fullest. He set up All4it and 4Clinics with the aim of perfecting client-oriented data “goldmining”.
The CRO structure has put into place specific procedures and dedicated teams and operates in full compliance with such rigorous standards as ICH, 21 CFR part 11.
Our panel of Clinical Data Management services includes:
- Protocol development/review support
- e-CRF design
- Paper CRF design and printing
- CRF completion guidelines
- Development of project documentation: Data Management Plan, Data Entry
- Conventions, Data Cleaning/Validation Plan, Data Management Report…
- Generation of annotated CRFs following sponsor/4Clinics standards
- Database design and set-up Database validation with dummy patients
- Data extraction, mapping, and pooling
- CRF tracking
- Data entry (double or interactive mode)
- Data cleaning: programming checks and testing, query management Medical preferred term coding (MedDRA, WHOdrug)
- Release of patient profiles and listings
- Conducting medical reviews
- Data quality control
- External data uploading (ECG, Ct-Scan, MRI, lab results, drug levels concentrations, PK data, etc.)
- SAE reconciliation between the safety database and the clinical database.
- Protocol deviations: definition, detection, and evaluation
- Regular reporting: metrics, study status Randomization list management
- Participation in the data/blind review meeting
- Database lock (interim and final lock)
- Data transfers
- DM study file maintenance and archiving
CONSULTANCY SUPPORT & STAFFING SOLUTIONS:
From years of experience, 4Clinics Data Management teams offer expertise in various clinical tools :
- ENNOV Clinical - Clinsight
- EDC and RDC tools, such as Merge and Marvin
4Clinics uses ENNOV Clinical and Clintrial to provide fully-integrated EDC, IWRS, and medical coding solutions. All solutions are robust and validated according to CFR Part 11. ENNOV Clinical is compatible with electronic or paper-based CRFs.
The 4Clinics Data Management team can guide you through the implementation of the CDISC-SDTM and CDISC-CDASH global standards to ensure consistency across different projects.
Our panel of Biostatistics services includes:
- Sample size and power calculations
- Statistical protocol development
- Randomization lists and code-breaking envelopes
- Statistical analysis plans and reports
- Programming and production of tables, listings, and graphs
- Independent data analysis center to perform interim blinded analysis, support for DSMB and IDMC
- Data pooling and integrated analysis (ISS, ISE)
- Statistical consulting for submission to regulatory authorities (FDA)
- Efficacy, immunogenicity, safety, and reactogenicity analyses
- Conversion of legacy data to CDISC-ADaM and CDISC-SDTM standards
- Development, verification, and validation of standard macros
- Data de-anonymization
CONSULTANCY SUPPORT & STAFFING SOLUTIONS:
Consultancy Support & Staffing Solutions
We provide outstanding and experienced short- to long-term on-site consultancy support for all types of clinical projects. Since 2004, 4Clinics Biostatistics has forged strong relationships with several leading pharmaceutical and biotech companies in drug, biologics, and vaccine development.
The 4Clinics Biostatistics team is experienced in initiating and supporting clinical trials through their conclusion. We provide expertise in late clinical phases (phase II/III and IV), including interim analysis for drug, vaccine, and epidemiological studies.
Our mission is to support our clients in pharma and biotech launch and conduct clinical trials by providing statistical expertise, clinical data programming, statistical analysis, and reporting. We also provide support for CDISC-related projects.
The Biostatistics team at 4Clinics is knowledgeable and experienced. All statisticians have at least a Master's degree in statistics, and all have SAS programming skills. In addition, all receive training in GCP and ICH standards and undergo regular intensive training to maintain their skills and knowledge of statistics.
Our dedicated Medical Writing team can provide the full range of medical documents required for your clinical program. This team is composed of highly competent professionals with fluency in English, French and Dutch, and includes native English speakers.
We can write, review, perform quality control, edit, and translate a broad portfolio of documents produced in accordance with the International Conference on Harmonisation (ICH) guidelines, including:
- Investigational Medicinal Product Dossiers
- Investigator's brochures
- Clinical study protocols
- Informed consent forms
- Clinical study reports
- Standard Operating Procedures
OUR PANEL OF PROJECT MANAGEMENT SERVICES INCLUDES:
Project Management plans include a communication plan, escalation(?), risk management, study initiation to close out activities, and timelines
Regular internal or external study meetings with sponsor and internal teams Development of Trial Master File (TMF) and Investigator Site files
Quality Control Plans include a procedure to escalate significant GCP non-compliance and regulatory inspections
Trial Status Reports (TSR)
Study Progress Reports
Submission of study reports to regulatory authority (e.g. CHMP), if needed
We can also write, review, perform quality control, edit, and translate a broad range of scientific documents tailored to your communication needs. These include:
- Manuscripts for medical and scientific journals
- Scientific abstracts, posters and slide presentations
- Patent descriptions
- Preclinical study reports
- Scientific literature reviews
- Website content
Our dedicated team of scientific writers can provide documents tailored to different audiences. The team is composed of highly-trained writers, most of whom have PhDs, who can produce a wide array of scientific documents
Starting from raw data, we can prepare polished manuscripts for publication in peer- reviewed journals in accordance with the CONSORT and STROBE guidelines. We provide assistance in all stages of the publication process, from first draft to submission and reviewer response.
Top 5 Recent Tweets
|March 13, 2018||4Clinics||Meet our team at the #worldvaccinecongress in Washington on April 3-5 at booth #119 to discuss about our #solutions… https://t.co/Yn7agyR0Ni|