Expert Biostatistics for Clinical Research and Life Sciences
Welcome to ACOMED statistik - Experts Biostatistics for Clinical & Diagnostic Studies –
Trusted by Sponsors and CROs in the EU and USA.
Since 2003, ACOMED statistik offers statistical services for clinical research.
- Biometrics for clinical trials: study protocol, SAP, SAS programming, analyses
- for the pharmaceutical, medical device and diagnostics industries and university research
- as a subcontractor for CRO
- tailor-made statistics seminars
- Focus: analytical and clinical performance of IVD
ACOMED statistik (owned by Dr. Thomas Keller, Leipzig, with 3 additional employees (statistician/biometrician on permanent contracts)) caters to scientists and physicians, product managers (marketing/sales, R&D), as well as other professional groups in industry (life sciences, pharmaceuticals, CRO, in-vitro diagnostics), research, and clinical laboratories. ACOMED statistik can point to high-ranking expertise, as evidenced by our references and contributions to scientific literature.
Biometrics, statistics and SAS programming for clinical trials, estimands
ACOMED statistik offers statistical services for the pharmaceutical, medical device, and diagnostics (IVD) industries. ACOMED statistik works both as a direct contractor and indirectly as a subcontractor for CROs.
Biometric planning (statistical consulting, study protocol, conception of
Estimands , Statistical evaluation plan (SAP), sample size determination) and evaluation (SAS programming, analysis, statistical report) of clinical studies as well as medical writing (contribution to the clinical report and publications).
IVD: Evaluation of in vitro diagnostics in clinical diagnostic studies/diagnostic studies, performance evaluation of IVD
ACOMED statistik supports you in the planning and analysis of clinical studies for the evaluation of diagnostic procedures (clinical performance evaluation of IVDs, clinical performance within the framework of EU Regulation 2017/746).
Diagnostic studies are a core focus of ACOMED statistics. These studies are supported by only a few CROs. We have over 20 years of experience in diagnostic studies. Benefit from our expertise!
Design and analysis of experiments for analytical method validation of IvD according to CLSI guidelines
ACOMED statistik offers statistical services for IVD manufacturers, clinical laboratories and laboratories in clinical research.
This includes the planning and evaluation of experiments, particularly the validation of analytical methods for IVD manufacturers and clinical laboratories. We also offer methodological studies and the programming of statistical analyses of experiments, such as the determination of values in the testing laboratory.
Dr. Keller particpated/participates in working groups of the CLSI, the IFCC, and the DGKL. Benefit from this expertise!
Statistics training
Statistics seminars
Statistics workshops
Statistics courses
ACOMED statistik offers statistics seminars. These seminars are conducted as online training or as in-house statistics training at the client's location.
Key areas for statistics training:
- Diagnostic studies
- Method evaluation and validation according to CLSI or IVD-R2017/746
- Statistics for medical professionals and natural scientists in life sciences
- Software training (statistics with Excel, evaluations with Analyse-It®)
Statistical analyses
We analyze given datasets using appropriate statistical methods. You will receive a report with a clear description of the materials and methods, a results section with informative and presentable tables and figures, as well as suggestions for discussion and interpretation.
Statistical consulting
Statistics advice
ACOMED statistik offers statistical consulting for companies and public institutions. Are you planning a study? What sample size is requireded? How will it be conducted? Should estimands be planned and analysed? How can a performance limit be set?
We can help answer these questions. Let's talk on the phone or via MS teams.
Why choose ACOMED? ACOMED statistik fills the gap between university statistics departments, CROs (Contract Research Organizations), and sometimes even corporate R&D departments. ACOMED statistik tackles your problems head-on, works in a customer-oriented manner, and relatively quickly – at least that's what many of our customers tell us. With ACOMED statistik, you'll find a company with expertise in biometrics, statistics, and medicine.
