Statistical programming
Our team consists of:
- Highly qualified and experienced statistical programmers (at least
BSc-level or equivalent)
- A large group of specialized programmers
- Experience:
- Development and validation of SAS® programs covering all
steps of a clinical development including the generation and maintenance
of integrated databases spanning all clinical trials of a project
- Preparation of data for submission to health authorities, e.g.
FDA
- Development of programs for the analysis of
- clinical trial data according to the specifications from internal
project teams and/or our customers
- pharmacokinetic data including data interchange with standard
pharmacokinetic tools
- non-clinical statistics data
- Generation of sophisticated and accurate outputs, i.e. tables, figures,
listings necessary in clinical study reports, drug submission dossiers
or internal decision making
- Generation of customized data displays (e.g. patient profiles, support
of external committees such as Data Safety Monitoring Board, publications,
etc.) in electronic and paper format
- Set-up and maintenance of global integrated data bases combining
clinical data across various trials throughout the life-cycle of a
pharmaceutical compound as needed for many kinds of overall analyses,
e.g. in NDAs, MAAs, etc., subgroup extraction or meta-analyses
- Preparation of datasets and documentation for submission to authorities
- An excellent access to a strong network of external consultants
allows us to enlarge our resource base in order to meet peak requests
- SAS® 6.12 and 8.2 under UNIX 11 and Windows 2000
- Proprietary SAS® development environment SASenv, including standardized
file administration and automated Clintrial®-SAS® interface
- to transfer data on a routine day-to-day basis from Clintrial®
to SAS® for consistency of clinical trial database and statistical
analysis datasets
- Proprietary ART-system for management of codelists, linked with
the automated export of data from Clintrial® to SAS®
- Interface to Oracle® Clinical in order to access study data
and codelists in SAS® in a standardized and validated manner on
demand
- Extensive library of SAS® macros and program modules for standard
statistical analysis, including evaluation of laboratory data, adverse
events, descriptive and inferential statistics, graphical data display,
etc.
- WinNonLin® for pharmacokinetic analyses
- DBMS-Copy® to exchange datasets with other software formats
- Proprietary interface for transfer of outputs into document management
system Documentum®
We work according to high quality standards and are compliant with
all relevant guidelines:
- Standardized directory structure implemented by our proprietary
SAS® environment application SASenv
- Analysis datasets are designed according to customer specifications
and/or industry standards, i.e. the FDA Guidelines for Electronic
Submissions and latest CDISC standards
- Comprehensive Good Programming Practices document complementing
our set of SOPs to take care of detailed recommendations such as all
data derivations are defined uniquely, etc.
- Program validation in line with regulatory requirements (GCP, ICH,
FDA and EMEA guidelines, especially ICH E9, FDA Guidance "General
Principles of Software Validation" and "Computerized Systems used
in Clinical Trials") and accepted industry standards
- Detailed program validation plan covering all aspects of program
development and validation
- Independent, senior-level review of all programs/outputs included
- Extensive library of SAS® macros and program modules for standard
statistical analysis including evaluation of laboratory data, adverse
events, descriptive and inferential statistics, graphical data display,
etc.
- Library of program modules for the analysis of pharmacokinetic data
- High integration of SAS® development environment with UNIX and
Windows®/Office® products
- Preparation of hyperlinked, ready to review datasets for the submission
to regulatory authorities
- Electronic transmission of all outputs into the document management
system Documentum®
- Dedicated team for analysis of phase I trials
- Dedicated team for the analysis of non-clinical data (stability
studies, assay validation, process validation, preclinical pharmacology,
etc.)
Our team has built a reputation for delivering fast, accurate programs:
- Support to over 20 submissions in the US, Europe and Japan since
1995 (Submissions)
- Analysis and generation of outputs for more than 100 clinical trials
since 1995, including global mega-trials with several thousand patients
(Track record)
- Full integration into project teams at Accovion and/or our clients,
if needed
- Strong experience in multi-site, multi-cultural projects (regular
collaboration with teams in France, USA and Japan)
- Main results usually available within 3 days after database closure
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