Our data management processes are based on industry´s best practices tailored towards the needs of phase 1-2 studies. Data management services cover electronic data collection, paper CRF data and processing of clinically captured electronic source data. All processes are clearly regulated by SOPs. All steps are clearly documented and you are involved in the review of key documents.
Data from the study site are validated according to the validation checks. After the validation process is completed the data are exported. Any missing, unreliable or inconsistent recording of electronic or paper based data are referred back to the investigator by utilizing a data query form and are documented for each individual participant before clean file status is confirmed. External data are imported into statistical program tables and merged with the study data. If external data have caused an unblinding, these data are merged only after the database is locked and unblinded.
Biostatistics and Biostatistical Programming Our biostatistician has vast experience in the design and analysis of phase I to III clinical trials ranging from parallel group design, cross-over design, pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, dose-escalation studies, pH-metric studies, euglycaemic clamp studies and bioequivalence testing. SOPs are followed, ensuring consistency and integrity of study results. On request, your study specific SOPs can be implemented. Our biostatistician can assist you in sample size calculation, statistical and pharmacokinetic argumentation, generating randomization lists, printing of emergency code breaking envelopes, and input and review of clinical study reports.
Medical Writing Highly qualified medical writers with extensive background in various indication areas assist in compiling, editing and reviewing all necessary clinical study documents from clinical study protocol to final report. All medical writers are flexible to meet your requirements and to efficiently produce the documents you need in time. The quality control processes and procedures are governed by our SOPs. After the clinical study is completed we also assist in writing a publication either as original paper or poster presentation.
Pharmacokinetic Services (clinical PK/PD) Our senior PK/PD specialist oversees all study related PK and/or PD activities. During the study life cycle, the early phase clinical PK/PD team interacts closely with PK-analysts (biostatistics) and medical writers.