Biometrics

Access to live data is a critical function to our offshore clients. With visibility in mind we provide all our Data Management services via EDC.

Our in-house system, Notare, allows for adaptive designs and incorporation of functions specific to our individual clients. Whether it is iPhone patient diaries or electronic third party adjudication of assessments, our team can provide it. Meeting customer needs via flexibility and forefront technology is what we pride ourselves on.

Our system and processes meet 21 CFR part 11 requirements including database design, documented testing, issue of data queries, audit trails and SAS outputs. Data Management is performed according to a Data Management Plan completed for every study in conjunction with staff and clients.

Our automated and manual processes for coding utilise industry standard dictionaries such as MedDRA and WHODRUG. External data, such as Laboratory data can be transferred electronically using our validated systems.

Quality assurance is built into our system through CRF reviews and critical variable review in addition to audits.

Statistics and Medical Writers

Our statisticians are amongst the most experienced in New Zealand providing statistical input into protocols, sample size justifications, and randomisation schedules.

Working with our statisticians we provide experienced medical writers with specific training in early phase trials who have an understanding of SAD/MAD studies, pharmacokinetics, safety and efficacy.

Data Transformation and Bespoke Software

Our experienced software developers and QA personnel allow us to create bespoke trial software integrating text based telecommunications and workflows. We adhere to CDASH standards and transform data into formats such as CDISC ODM and SDTM for data submission.