Pharmaceutical industry, research institutes and hospitals are doing research for better pharmaceuticals and more effective therapies. Data resulting from clinical trials establishes the essential basis for new findings in medical science. No new medicament may be approved for the market without a valid proof for its effectiveness and tolerance.
Protection of Participants in Clinical Trials
The conduct of clinical trials and data management underlie legal regulations. These regulations serve for the protection of the trial participants as well as for worldwide standardisation and quality assurance. Therefore, high requirements are set for the collection of data as well as database programming and validation.
Regulations concerning Good Clinical Practice, specifications for data security and system validation requirements are regularly updated. We are meeting this new challenge.
Coordinator in Sensitive Areas
As project coordinators and managers, we are the central linchpin within the legally sensitive area of clinical trials. We keep contact with ethics commissions and public authorities, as well as being significantly responsible for planning, preparing and conducting clinical trials.
Linking Pin between Initiator and Physician
As monitors, we are the tie between initiator and physician. We verify the original data on site. In this way we ensure the quality in clinical trials with pharmaceuticals or medical devices.
Guaranteeing Data Quality
As Clinical Data Manager, we provide for the coding of comorbidities and unwanted occurrences, thus taking care of correct data capture. Within this workflow, implausible data is checked with the monitors and the study site, before being statistically processed. With data being available in electronic form at a progressive rate, it has to be securely transmitted via internet and reliably saved in databases. For electronic data exchange, international standards exist. We are putting these guidelines into practice.
Success through Data Analysis
Only a methodically flawless data evaluation guarantees the success of a clinical trial, as only valid data can provide the basis for an authority’s decision to approve a medicament for the market. As professionals for statistical & clinical programming we provide the necessary tools for these data evaluations.