4Clinics

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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”).

They have 4 principal locations where their offices are located, the principal in Belgium , Waterloo and the others in Morroco, Abderrahmane; France, Paris and USA, Massachusets.

http://www.4clinics.com/
4Clinics
Type Private
Industry Pharmaceuticals
Founded 1998
Headquarters Waterloo, Belgium
Key people CEO; Xavier Ghyssens (M.Sc.)
Number of employees 180 employees
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History

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.

Management Team

Xavier Ghyssens (M.Sc.) - Chief Executive Officer

Xavier obtained a Masters Degree in Physics and 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”.

Anne Hepburn (PhD in Medical Biology) - Medical Writing & RA Director

Anne has been Director of Scientific Writing & Regulatory Affairs Services at 4Clinics since 2006. She is a native English speaker and came to 4Clinics with nearly 20 years of experience in clinical research and regulatory affairs. She has extensive experience in preparing clinical trial documentation (protocols, investigator brochures, study reports) and regulatory submissions. She has also written or co-written peer-reviewed articles for pre-clinical and clinical studies.

Mohamed Amakrane (M.Sc.) - Biostatistics Director

A Mathematics background together with 5 years of academic experience in applied statistics and worked as a Statistician and Project Statistician at IDDI from 2003 to 2005 before joining 4Clinics.

David Darcaigne (B.Sc.) – Data Management Coordinator

David has a bachelor’s degree in Bio medical Sciences from Université Catholique de Louvain (UCL). He has more than 9 years of experience in Data Management services and joined 4clinics in 2006.

Christophe Grenot – Director Clinical Operations

Christophe is Clinical Research professional with 20 experience in conducting EU and FDA-regulated trials in a broad range of therapeutic areas. He started his career as nurse in various specialized services before joining the medical device industry at Johnson & Johnson Interventional Systems (now Cordis) as a clinical monitor and clinical research associate. He then joined MedPass International, a full service medical device CRO, where he held the positions of Project Manager, Sr PM, and spend 7 years as the Director of Clinical Operations. He led a number of successful clinical projects for start-ups at the forefront of technological advances. Before joining 4Clincs in 2017, he provided independent consulting services for 4 years to medical device industries in designing, setting up and following clinical development programs.

Mehdi Chelbi (M.Sc.) - Business Development Director

Mehdi graduated in biology from the Lyon 1 and Lille 1 universities. He has 12 years of experience in Business Development and International Sales Management in life science. His client-oriented culture ensures the establishment of a high quality and sustainable relationship with pharmaceutical, biotechnology and life science companies. In his former position, Mehdi was business development manager for a CRO providing preclinical and drug discovery services. He interacted with research labs, biotechnology companies, healthcare and pharmaceutical companies.

SERVICES:

Their main services are

  1. Data Management.
  2. Biostatistics.
  3. Medical Writing.
  4. Study Management.
  5. Clinical Operations Support.
  6. Regulatory Affairs Support.
  7. Scientific Communication.

DATA MANAGEMENT:

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 :

  • Clintrial
  • ENNOV Clinical - Clinsight
  • SAS
  • 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.

BIOSTATISTICS

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.

MEDICAL WRITING

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
  • Narratives
  • 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

SCIENTIFIC COMMUNICATION

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.

Controversies

Top 5 Recent Tweets

DateAuthorComment
April 04, 20184ClinicsCome to meet us today at booth #119 in #Renaissance #WashingtonDC #DowntownHotel, to discuss our #solutions and… https://t.co/Y26sjFGOqo


Top 5 Recent News Headlines

  • 4 Clinics announced they will be attending the Boston-Paris Biotechnology Summit in June 3, 2018., which will take place in The Exchange Conference Center.

Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

References

http://www.4clinics.com/fr/about-us.html

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