Study planning

Pharmaceutical studies are subject to special quality requirements. e.factum provides you with its expertise as early as the planning phase of your study, supporting you with the following steps:

• • Concept development
• • Creation of the study/observation plan and statistical analysis plan
• • Sample size calculation
• • Handling of the review by the Ethics Committee
• • Registration with the authorities

Data collection

Complete, consistent data sets are an important prerequisite for obtaining meaningful study results. The formal design and content of the data collection materials are also of decisive importance. What is needed are didactically prepared forms that are understandable and easy to manage for the participating doctors.
 

We offer design consultation services and assist with the realization of the documentation materials in your desired format:

• • Development and implementation of online data collection (eCRF; electronic CRF) . Field staff, study management and product management can be assigned varying levels of administrator access and retrieve information such as current numbers of completed documentation or fees paid.
• • Even very large studies (> 10,000 patients />100 pages in CRF) are possible.

Study implementation

Our clients' employees can find out the status of the data collection from an Internet application provided by e.factum. For this purpose, selected employees receive a user name and a password with which they can log in and retrieve the data.

On request, e.factum can also serve as the return address for forms, perform the adverse events review and determine if data is missing.

• • Pharmacovigilance services: Processing of adverse events.
• • Query builder and CRF tracking.
• • Ongoing correspondence with authorities relating to the status of data collection.
• • Processing is accompanied by regular status reports on the observational study and the management of billing-related variables, all the way through to the doctors' fees.

Monitoring

Monitoring in non-interventional studies is a possible quality assurance measure recommended by BfArM and VfA. Our monitors have conducted on-site visits to study centres on behalf of our clients in numerous non-interventional studies.

Our experiences from these visits show significant differences from monitoring in clinical trials, which are conducted at experienced study centres, since the practice centres participating in non-interventional studies generally have little experience with monitoring, so that the announcement and implementation of an on-site visit is a special challenge that requires good communication and tact. Benefit from our experience.

Data analysis

Our range of post-data collection services includes:

• • Analysis plan
• • Programming
• • Database and screen creation
• • Data entry and verification
• • Data validation and query management
• • Coding of diseases, medications and adverse events
• • Data listings, descriptive statistics and significance tests
• • Meta-analyses
• • Statistical report and integrated medical final report

If the results require further preparation, we can support you in creating graphics and illustrations, compiling the data in the form of a poster, or drafting a publication.

Medical writing

The long-term market success of a medicinal product is supported by effective information and communication about the key product benefits.

e.factum designs and creates:

• • Statistical reports and integrated final medical reports
• • Publications in German or English
• • Posters, handouts or lecture materials for conferences, conventions and meetings
• • Brochures, product monographs and training materials in print or online
• • Medically sound and didactically optimized information materials regarding the mode of action, indications and tolerability of drugs for doctors, patients and field staff

Upon request, designed materials can also be printed and assembled.