McCloud Consulting Group

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.

Clinical data management

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.

Development of electronic case report form 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:

• Development of the data management / quality plan / validation specifications, and the electronic case report (eCRF) or paper CRF
• Thorough protocol review from a data management perspective to ensure appropriate data is collected at a specific time
• Train sites and monitor eCRF completion
• Database build and coding of discrepancy checks
• Data discrepancy management as specified in the data validation plan
• Medical and drug coding
• Liaising with laboratories to smoothly upload laboratory data
• CDISC compliant deliverables
• Reconciliation of adverse event data

McCloud Consulting implements the OpenClinica eCRF database solution, which provides the efficiencies of an eCRF solution.