- Europe, North America
- United Kingdom
- Human Medicines, Biopharmaceuticals
- Service category
- Clinical development and testing, clinical CRO, Regulatory services - CMC writing - medical writing, …
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- Clinical data service / data management
- Clinical R&D
- Clinical studies Phase I-IV
- Clinical studies planning
- Clinical trial services
- Contract research
- Drug safety
- Electronic data management
- Pharmacovigilance services
- Protocol writing
- Report writing
- Statistical service / biostatistics / biometrics
- Strategy consulting
"We know that sound statistical advice will save both costs and time."
We are obsessive about the details - we do not rest until every table, figure and listing is of the highest quality. Regulatory filings are something of a speciality at Cerafor and we make sure the data are presented to agencies exactly as they require.
There is no statistical problem for which we cannot provide a solution, and we enjoy a challenge…!
Statistical Advisory Council
Our Statistical Advisory Council comprises leading industry and academic biostatistics experts who advise on your most complex statistical challenges and tasks.
Planning and writing statistical analyses
Correct statistical analysis planning is an integral part of an efficient clinical study. We use the best-in-class techniques to deliver the earliest possible technical success.
Analysis dataset creation
We work to your standards or CDISC compliant datasets (including define.xml creation).
Programming and production of tables, figures and listings
As part of our Statistical Analysis Plans (SAPs), we provide a full suite of table, figure and listing shells to meet your requirements and relevant regulatory authority standards.
Producing statistical reports
In addition to providing input into Top Line Reports (TLRs) and Clinical Study Reports (CSRs), we can provide standalone statistical reports adapted to your specific requirements.
PK and PD modeling
By predicting the effect and efficacy of drug dosing we can help you design the right study, aid decision-making and predict the likelihood of success.
Data Monitoring Committee and regulatory support
We provide expert support at all levels, from provision of blinded and unblinded statisticians at Data Monitoring Committees through to participation in global regulatory meetings.
Design, analysis and reporting of adaptive clinical trials
We are experienced in the design and implementation of ‘next-generation’ trials and their analysis.
Data pooling and meta-analyses
By contrasting and combining results from different studies we can enable a better understanding of clinical effectiveness, minimising bias and ensuring accuracy and transparency.
"Taking the right statistical approach is only half the battle – it is just as important to know what data to collect and how to database it."
We understand how best to manage your data. We ensure that only reportable data are collected and managed in a way that complies fully with regulatory requirements.
We tailor our services to give you optimal results - we have our preferred methods and tools for collecting data but we are ready to use your systems if you prefer. The only things we will not compromise on are our quality standards that produce superior results and satisfied clients.
We get studies off to the best possible start, whether using an EDC or paper-based system. Logical CRF design, rapid clinical database build and deployment, and quality edit check programming all expedite project start-up.
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