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Database Design
SPC is using different Database Systems for the development of customized databases. Our database system supports data entry, data management and electronic filings.
MedDRA
To assist pharmaceutical companies to implement The Medical Dictionary for Regulatory Activities (MedDRA), Swiss Pharma Contract makes available its experienced personnel: see under “Consulting” for our service.
Double Data Entry System
SPC has developed a customized Double Data Entry System that is modular in design, allowing for ease of programming for individual projects to support our varied client needs. This system in also available for set up and support at the client site for those companies that are interested in creating their own data management.
Data Management
SPC Data Management Staff is involved from the beginning with CRF-Development, data collection guidelines, database specification and logic checks design. Our Data Management team performs double data entry, coding, automated data clarification forms, database editing and quality control reviews.
Statistical Programming
Statistical Programming in SAS gives SPC the capability to generate tables, listings, and analysis as well as the development of specialized software to manage, analyze, and display data. Statistical Programming is done concurrently with clinical conduct of the study to shorten time lines from last patient visit to database lock and statistical report.
Pharmacokinetic Analysis
Pharmacokinetic data are an essential part of the comprehensive safety evaluation of a new chemical entity as well as in the development of new galenical forms or generic dosage forms. Concentration data are analyzed with the aid of commercially available software (WinNonLin Pro) to define the pharmacokinetic parameters of the compound and/or its metabolites. Beyond the model independent analysis, model dependent pharmacokinetic analysis and pharmacokinetic/pharmacodynamic analysis can be performed upon request.
Drug Disposition
Dose Linearity
Relative Bioavailability/Bioequivalence
Absolute Bioavailability
Bioaccumulation/Bioretention
Metabolite Pharmacokinetic Characterization
Rates of Biotransformation
Rates of Excretion
Steady-state Pharmacokinetics
Routes of Administration
Oral
Intravenous (bolus)
Intravenous (continuous infusion)
Transdermal
Sublingual
Eye-drops
Buccal
Intramuscular
Subcutaneous
Nasal
Rectal
Please contact:
Rolf Pokorny, M.D., M.Sc.
Head of Clinical Research/Biometrics
Lettenweg 118
CH-4123 Allschwil , Switzerland
Tel.: +41 / 61 / 487 24 00
Fax: +41 / 61 / 487 24 01
e-mail: rpokorny@pharmacontract.ch
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