Database

ATLANSTAT

Solution provided
Technology
Supplier identity
General description

Contract Research Organization in Cinical trials set up : Monitoring, Data management, Biostatistical analyses and Medical Writing sponsored by the Pharma industry, Biotechs or Public Research - Consultancy in statistical methodology

Type of Supplier
Service Provider - CMO / CRO
Region
Regions of Pays de la Loire, Centre and Poitou-Charentes, FR
Regional access broker
  • Grégory Bauer, Atlanpole Biotherapies
Activity description
The 3 top equipments available

CLINICAL OPERATIONS/ MEDICAL WRITING

DATA MANAGEMENT

BIOSTATISTICS

Know-how, expertise available

CLINICAL OPERATIONS/ MEDICAL WRITING

Our Clinical Operations Department provides and ensures our client’s with a complete project management plan in accordance with Good Clinical Practices (GCP) and Standard Operating procedures (SOP). For all kind of studies, AtlanStat provides:

  • Identification of medical leaders/experts in specific therapeutics,
  • Selection of Investigators sites,
  • Conception/Writing of the clinical study protocol,
  • Health authorities and regulations management,
  • Investigators meetings, Study sites set up, Monitoring and centres follow up,
  • Project Global management, Study sites ending
  • Medical Writing of safety narratives and Clinical Study Reports

DATA MANAGEMENT

AtlanStat guarantees the integrity of your study documents and data by utilizing stringent quality control and quality assurance measures, processes and management procedures in accordance with all International regulations and guidelines.For all kind of studies, AtlanStat provides:

  • CRF design using CDASH/CDISC as well as specific domains,
  • Data base set up (Oracle),
  • Data imports/exports handling,
  • Data Validation (automatic/manual),
  • Edition of trackers and metrics data,
  • Programming / validation / edition of patient profiles and individual data listings,
  • Medical Data coding (MedDRA, WHODRL),
  • Pharmacovigilance database reconciliation,
  • Final quality control, data entry audits,
  • Blind data review,
  • Database lock and transfer 

RANDOMIZATION

  • AtlanStat has developed validated Interactive Web Response (IWR) systems to allow randomization of clinical trials.

BIOSTATISTICS AND STATISTICAL PROGRAMMING

AtlanStat is composed of qualified biostatisticians and statistical programmers. Our team is repeatedly invited to participate in International Experts Committees.For all kind of studies, AtlanStat provides:

  • Methodological Approach: writing of protocol statistics sections, number of subjects calculation, randomisation schema,
  • Statistical Analysis Plan writing,
  • Statistical Analysis programming,
  • Full Validation and quality control of results,
  • Set up and programming of interim- or meta- analyses,
  • Set up and programming of specific data (PharmacoKinetics / ToxicoKinetics)
  • Writing of all statistical parts of Clinical Study Report (ICH).
Market expertise
AtlanStat has managed more than 220 International clinical projects for our pharmaceutical, academic and medical device clients in addition to supporting two drug submissions to FDA. 
Training and Staff possibilities
No
Contact information
Name
GODFROID-HUGONET
Surname
Nadine
Function
President and CEO
Phone number
+33 (0)2 40 63 16 60
Address
3 rue Jules Verne
44405  Rezé cedex
France