McCloud Consulting Group Biostatistics and Data Management

McCloud Consulting Group specialises in biostatistical and clinical data management services for the pharmaceutical, biotechnology, medical devices, and healthcare sector.

Biostatistics and data management for pharmaceutical clinical trials

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.

Biostatistics for oncology and virology and other therapeutic areas

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.

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.