Data Management and Statistics

At Bielderman, in our Data Management department, we cover every aspect of Data Management and Statistics, e.g. CRF design, data entry, database design, data validation, statistics and consultation.

Our highly skilled personnel

• adheres to the European Clinical Trial Directive and GCP which is officially applicable to medical device studies
• uses the unofficial Good Clinical Data Management Guideline as guide, and
• works from the philosophy that data quality comes through speed, transparency and experience

These 3 requirements are reflected by our Data Management System, DataPOX, and our Statistical software, SIASE. It is our experience that Investigators strongly adhere to a paper based CRF and that electronic CRF solutions are inadequate and disturb their busy schedule. They do not want to do the time-consuming aspect of the insertion of the clinical data. DataPOX combines the advantage of a paper based CRF while benefiting from electronic data transfer by facsimile.

CRF design

With our inside knowledge of the surgeon’s routine, we can design CRFs efficiently to obtain reliable data for primary and secondary endpoints. The study database is built, based on a SIASE-annotated CRF.

Data entry

As well as standard double data entry, our clients can also choose between computerized data entry which may be an excellent choice for Post-marketing trials, and computerized data entry with verification, which is much more time and resource efficient.

Database design, data validation, database lock

Our databases are designed using the PAASRTF GROP model as a guide. The study database setup is therefore guided by the SIASE-annotated CRF. With the database in place a Data Validation plan is made that contains all checks for your study, electronic as well as manual. Electronic checks are programmed to either pop-up during data entry or data validation, or to be run in a separate batch. Subsequent queries are sent and received by fax to ensure a speedy query turnover which results in higher quality data as the information is still fresh in the Investigator’s memory.
When the cleaning process is finished, a quality control check is performed on the database, after which the database is locked and ready for statistical analysis.

Reporting

During the trial we will keep you up to date about your study’s progress by providing you with automated reports that are sent by our Data Management System on a weekly, daily or even hourly basis. In addition, more extensive study overviews can be made with SIASE and can be customized to your wishes.

Statistics

Prior to, during and after a study, many questions play a role. Before your study commences, we may consult you on the required population size to meet your targets, and review or write the section on the statistical considerations in your study protocol. During your study, we provide interim analyses and after your study we may assist you in analyzing the study data, assist in “translating” the statistical report and help you in writing the final report.

Data Management Consultation

Next to data management services our Data Management department offer consultation on the data management process such as protocol review, and setup of SOPs for your starting data management department.

Reimbursement

Reimbursement is the process whereby the cost to a healthcare provider (e.g. doctor, hospital, pharmacy, etc.) for supplying a medical product to a patient is met by a third party, i.e. either by a public National Health Service or private medical insurance. Typically, the product in question must be 'approved' by the third party payer in order for the healthcare provider to receive payment.

Some form of a reimbursement approval for medical products is currently required by state-organized and insurance-based healthcare systems in all the major markets around the world. Accordingly, obtaining the appropriate reimbursement status for your medical device product is of vital importance for effective market access and achievement of optimum sales potential.

Bielderman will assist you in obtaining reimbursement approval for your medical device products by providing the following services:

• Identification of the type of reimbursement system into which the product falls
• Identification of factors important for the economic evaluation of your product, such as cost per patient day, cost effectiveness and cost benefit compared with existing treatments
• Advice on the best time to submit the reimbursement proposal, taking budgetary cycles into consideration
• Completion and submission of the documentation required by the respective reimbursement authorities
• Liaise on your behalf with reimbursement authorities during the approval