88122
(02) 9719 2800
"1605"
PO Box 220, FIVE DOCK NSW 2046
Datapharm Australia team takes very seriously its obligation to protect the privacy, confidentiality and security of all information entrusted to us.
Our data management specialists are highly experienced in handling medical and scientific data. All data is thoroughly reviewed by appropriately trained and experienced staff to ensure data integrity. All our data management processes are regulated according to closely controlled SOPs and in accordance with ICH GCP, FDA 21 CFR part 11 and CDISC/CDASH standards. These established data management systems can offer you significant time and cost savings.
Description:
Services
Our experts in clinical trial management, data management, statistics, medical writing and pharmacovigilance work in close collaboration, ensuring all the critical elements are considered in the design of your clinical trial.
Respected for our expertise in clinical trial management, we can assist with all aspects of this service including feasibility, clinical trial design, preparation and co-ordination of ethics and regulatory submissions, clinical trial site monitoring, tracking of trial progress, preparation of clinical trial and confidentiality agreements, site start up and close out.
Clinical Trial Monitoring Services
Datapharm Australia monitoring services have always been fundamental to our operations. Our extensive national and international experience over a wide range of therapeutic areas has brought Datapharm well deserved respect and admiration for the standard of monitoring services offered.
Datapharm Australia’s expert data management team with experience across a wide range of therapeutic areas and high level of attention to detail will custom-design your paper-based case report form (CRF) or electronic data capture (EDC) or ePRO systems to suit your trial, protocol and budget.
Delivering expertise and excellence in electronic and paper CRF design, data entry, development of data management plans, data cleaning, coding of adverse events, medical history and medication and data listings.
Our highly experienced team of statisticians can provide statistical and biostatistical analysis, SAS programming, database setup, statistical input into clinical trial design, sample size calculations, and more.
Medical and Scientific Writing
An experienced team of PhD and MBBS writers can provide medical, scientific and academic writing including clinical trial protocols, Investigator Brochures, ethics submissions and informed consent documents, clinical trial reports, publications, promotional material (including presentations), and more.
Medical Monitoring and Pharmacovigilance
Our medically qualified personnel are able to offer a wide range of medical monitoring and pharmacovigilance services to support your product development.