Biomedical Engineering and Advanced Manufacturing Centre, Ontario, Canada
The Biomedical Engineering and Advanced Manufacturing (BEAM) centre is located in McMaster Innovation Park in Hamilton, Ontario, Canada.
Biostatistics and Data Management
Unit 13 / 23 Narabang Way,
Belrose,
2085 New South Wales,
Australia
McCloud Consulting Group specialises in biostatistical and clinical data management services for the pharmaceutical, biotechnology, medical devices, and healthcare sector.
McCloud Consulting provides biostatistical and data management services for all stages of clinical trials, including statistical design, sample size calculation, CRF design, database build, discrepancy programming, locking the database, and writing and contributing to statistical and study reports.
The vast majority of the company’s team of biostatisticians and data managers each have ten to 20 years of experience in the pharmaceutical and biotechnology sectors, enabling the development of astute clinical trial designs.
McCloud Consulting is experienced in a wide array of statistical applications, and have been lead statisticians for a range of global development programmes, resulting in global regulatory approvals.
The team understands how to answer health authority questions during the new drug application and at the time of approval.
Biostatisticians specialise in many therapeutic areas, including oncology, virology, immunology, cardiovascular, neurology, and metabolism. The team reviews and writes the statistics sections for numerous protocols from Phase I-IV studies.
They also offer expert advice and statistical analysis to health economists for various subject matters such as meta-analysis, indirect comparisons and extrapolation of survival curves.
McCloud Consulting understands that clients prioritise the integrity, security, and validity of their data.
The clinical data management team have worked at the highest levels of the pharmaceutical industry, and provide project management skills that ensure a timely lock of the database.
McCloud Consulting manages clinical trials from Phase I to IV. The clinical data management team deliver high-quality data for specific projects.
Procedures in the company’s data quality plan include:
McCloud Consulting implements the OpenClinica eCRF database solution, which provides the efficiencies of an eCRF solution.
The Biomedical Engineering and Advanced Manufacturing (BEAM) centre is located in McMaster Innovation Park in Hamilton, Ontario, Canada.
Unit 13 / 23 Narabang Way
Belrose
2085
New South Wales
Australia