Biostatistics · Data Management · EDC
From study design and sample size to a locked database and a final statistical report, on our EDC system, StatistX supports clinical trials in line with ICH GCP and 21 CFR Part 11.
Services
A complete data management service, compliant with ICH GCP and 21 CFR Part 11.
The right design and the right outcomes improve the odds of a successful trial. A sample size based on the primary outcome, calculated with the method that fits the study, helps reach the trial's goals without the cost of an oversized sample.
Producing a statistical report from a raw database is much like sculpting a statue from raw rock: the shape of the result is hidden in the numbers. We work with integrity and report the results as they are.
The StatistX EDC
A complete, validated EDC for clinical trials, with randomization, ePRO and safety reporting built in. Designed, hosted and supported by StatistX.
Visual form and visit-schedule builder, standard CDASH forms, skip logic, calculations and edit checks. Versioned releases and test copies.
Subject page and visit grid, checks as you type, lab results flagged against each site's normal ranges, adverse event and medication logs.
Automatic and manual queries, source data verification, MedDRA and WHODrug coding, investigator signatures, and locks from a form to the whole study.
Your lists, per study or per site, with stratification and eligibility checked from the forms. Blinded or open-label, with emergency unblinding.
Diaries and questionnaires on the subject's phone, in multiple languages, with reminders, compliance tracking and safety alerts to the site.
Serious adverse events reported from the AE log, with the 24-hour clock, the investigator's signature and the sponsor's distribution list.
Excel, CSV, SAS, SPSS and R files with labels and formats, and CDISC SDTM with define.xml.
An audit trail kept by the database itself, electronic signatures, reasons for change, roles per study and site, two-factor login.
On Amazon Web Services, with nightly backups and monthly restore tests. IQ and OQ reports with every release.
Send us the protocol: we draft the whole study design, you review it and try it in a test copy before going live.
Protocol amendments become new design versions; the data follows, and every step stays in the audit trail.
Reports on enrolment, overdue visits, open queries, SDV and signatures by site, in Excel or PDF.
Training for your team, a built-in help centre with required reading and training records, and fast answers.
You work directly with the experienced biostatistician and data manager who built the system, from the first draft of the study to the final export. No call centres, no ticket queues: your questions reach someone who knows your trial.
About us
At StatistX we take pride in a healthy working culture. We keep learning and improving, so that we can always offer best-in-class solutions.
Our team includes senior biostatisticians and epidemiologists, experienced field medical staff, trained clinical trial monitors and skilled data management programmers, with backgrounds in epidemiology, public health, nursing, psychology and psychiatry.
Contact
Send a short description of the study and what you need. We usually reply within one working day.