High quality clinical data and meaningful bio statistical reports are key to generating the clinical evidence needed for regulatory and reimbursement approvals of medical devices
MedPass has full biometrics capabilities using 21 CFR Part 11 compliant Electronic Data Capture (EDC) with inhouse data managers and biostatisticians highly experienced in processing and analyzing clinical data from all phases of medical device clinical investigations.
EARLY INVOLVEMENT ENSURES MEANINGFUL DATA COLLECTION
The MedPass biometrics team is involved from the start of the clinical investigation to ensure that study design and sample size are appropriate and data collection will meet the needs of the planned data analyses while being user friendly for investigational sites.
EFFECTIVE DATA MANAGEMENT KEEPS TRIALS ON TRACK
Throughout the study, effective data management can be a real asset to drive clinical project management. MedPass’ skilled data managers track key information such as protocol deviations, adverse events, missing and inconsistent data. Communication with the sponsor and clinical project team ensures that corrective actions can be taken as necessary in a timely manner.
BIOSTATISTICS JUSTIFY SCIENTIFIC VALIDITY
MedPass’ in-house, skilled, SAS certified biostatisticians can develop the clinical analysis plan and then perform the programming necessary to produce interim and final analyses using the latest version of SAS.
We also perform data coding and safety data reconciliation.