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Sourcing Inquiry Logo Cerafor

Cerafor

Regions
Europe, North America
Countries
United Kingdom
Size
20-50
Specialty
Human Medicines, Biopharmaceuticals
Service category
Clinical development and testing, clinical CRO, Regulatory services - CMC writing - medical writing, …
Service category
Clinical development and testing, clinical CRO, Regulatory services - CMC writing - medical writing, Pharmacovigilance and QPPV services
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Key services

Services

Biostatistics

"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.

 

 

Data Management

"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.

Data management planning

We produce well-defined, tailored Data Management Plans (DMPs) for effective project management and timely delivery of clean databases.

Study start-up

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.

Core data management

Throughout the study we proactively manage the data, including edit-checking and discrepancy management, to reduce costs and delays.

Centralised data monitoring

Through centralised data monitoring we can identify missing data, perform consistency checks, verify source data and identify screen failure rates. This reduces the need for costly site visits.

Medical coding and medical data review

We offer both manual and automatic coding. Our processes ensure minimal variability in data reporting and analysis to achieve better reconciliation between safety and clinical databases, and consistent use of dictionaries.

Quality control

By applying our rigorous QC standards, we ensure robust data quality to underpin study findings and meet regulatory requirements.

Output of data to industry standards

We work to industry standards, including CDISC foundational standards. Through centralising your data with Cerafor you avoid the need for downstream data mapping and conversion.

 

 

Medical Writing

"Our experienced medical writers produce a wide range of high quality documents for clinical studies across all therapeutic areas."

Whether for a report, protocol, investigator brochure or any other document required for clinical studies, we deliver medical writing that meets project needs and complies with SOPs and regulatory requirements.

Our medical writers are highly qualified, native English speakers, so you have access to a high level of medical writing expertise to produce accurate and timely documents. We provide expert translation services when other languages are required.

Protocols and clinical study documents

Whatever the study or indication, we prepare concise and accurate protocols, informed consent documents, investigator brochures and educational material, ensuring the study is fully understood by clinicians and patients.

e-Document publishing

We produce hyper-linked PDF documents to enable rapid submission of clinical study report documents to regulatory agencies.

Regulatory submissions

We produce summary documents for regulatory submissions and provide QC support to ensure all regulatory documents are consistent and accurate.

Clinical study report synopses for public disclosure

We offer clear and informative reporting of summary results of clinical studies to ensure accurate and compliant disclosure.

Scientific publications and posters

Our publication services facilitate sharing of clinical study results with peers and the research and medical communities.

Safety narratives

We prepare a full range of regulatory safety narratives to any level of detail, as required for clinical study reporting.

 

 

Pharmacovigilance

"Patient safety always comes first, but ensuring effective drug safety management and pharmacovigilance can be challenging, time consuming and expensive."

We can provide a suite of expert pharmacovigilance services to ensure you remains compliant with all current and future international regulatory standards.

Across your portfolio of products in development and on the market you will be assured that safety data are being continuously, rigorously and efficiently monitored to minimise risks to patients.

Secure and compliant safety database

Our fully validated safety database is at the hub of our pharmacovigilance services and facilitates rapid assessment, processing and global reporting of clinical study and spontaneous adverse events in compliance with international regulatory standards.

Case evaluation and expedited reporting

24-hour, 365-day support from our team of experienced drug safety physicians ensures timely medical review, assessment and reporting of clinical study and spontaneously reported adverse events.

Periodic reporting

Our expert medical writers and pharmacovigilance experts will produce both your Development Safety Update Reports and Periodic Safety Update Reports.

Signal detection and evaluation

Our expert drug safety physicians will evaluate cases on an ongoing basis and develop signal detection strategies for implementation over the longer term.

Literature screening and review

To ensure your compliance with regulatory requirements we can provide global literature screening and review services to monitor for new safety signals or emerging safety issues and reportable events.

Quality assurance

We provide expert QA and training services to ensure inspection readiness and address inspection findings including preparation of CAPAs.

Safety database management and reconciliation

Our data managers will reconcile specific data points associated with SAEs entered on to a safety database and a clinical database to ensure consistent reporting to the authorities.

 

 

Consultancy and Specialist Services

"Cerafor has the experts with the knowledge and experience to recommend and deliver pragmatic, workable and cost-effective solutions for your most complex biometrics challenges."

We can advise on optimal strategy, operations and processes, timelines and costs at an enterprise, programme, or clinical study level and then help you to deliver the solution.

This means you have access to specialist biometrics expertise whenever you need it.

Rescue of under-performing clinical studies

We have successfully rescued failing studies by rebuilding trust, clarifying priorities, and improving processes. We can reinvigorate and restore your underperforming projects.

Mapping of legacy clinical study data to CDISC standards

Potentially valuable trial data can be inaccessible and unusable. We undertake ‘intelligent mapping’, with cost-effective and expedited approaches to consolidate data to CDISC standards.

Integrated safety and efficacy summaries for global regulatory submissions

We are experienced in delivering high-quality ISS/ISE outputs and reports in required regulatory formats and to CDISC standards.

EDC solutions

Our working experience of many database systems allows us to rigorously specify, select and deploy an appropriate EDC solution for you.

Programme design

Our experts will help you design programmes that will optimise your clinical development and gain regulatory approval.

Advisory boards and steering committees

Members of our Statistical Advisory Council are available to participate on advisory boards and steering committees to advise on your product development.

Resourcing

As well as recruiting experienced statisticians, programmers, data managers and medical writers to supplement your team, we will provide biometrics teams under functional service provision (FSP) arrangements.

Outsourcing plans and implementation support, including FSP and strategic partnership arrangements

We advise on biometrics outsourcing options, from transactional arrangements through FSP alliances to strategic partnerships, and assist with implementation and management.

Other consultancy services

These services include operational strategy, process and systems redesign and implementation support, team roles and responsibilities and tailor-made trainin

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