FAQ
Frequently Asked Questions
Contact us by
email
or leave a message in the
contact
form.
For your specific questions please don’t hesitate to contact the Pharmacelsus scientists directly to discuss how our services can help to accelerate your drug discovery program and to optimize your test strategy.
How to set up a study at Pharmacelsus?
Our services are tailor-made to ensure you get back information in the form that you require, not only using our in-house assay protocols but also customising specific protocols individually. At Pharmacelsus, a dedicated
project coordinator
whose skills best matches the requirements of the client, will be responsible for the study. Their role is to act as the first point of contact and to ensure all data is reported to the sponsor in an appropriate format and a timely manner. The project coordinator will set up a study proposal (quotation) including time lines, costs, experimental details and conditions. This offer is without engagement.
The Pharmacelsus scientists are pleased to set up a tailor-made study proposal for specific needs. For ordering a study, please provide us with the signed study proposal by fax, email or mail.
How to submit test items?
Test items can be submitted to Pharmacelsus in 100% solvent (ideally acetonitril, or DMSO if acetonitrile is not applicable) or solid. Sample amounts below 2 mg should be submitted accurately weighed.
How are test items stored at Pharmacelsus?
Upon receipt, the sponsor will be notified that the test items have arrived. Test items are stored by default at 4°C unless the sponsor specifies alternative storage conditions. Pharmacelsus requests Material Safety Data Sheets for each test item.
How are samples prepared?
Test item solutions are visually inspected for any solubility issues. Any signs of precipitation are noted and recorded. Any remaining test item, stock dilutions or retain samples will be disposed of 2 months after submission unless otherwise requested by the sponsor.
How are data recorded and analyzed?
It is the responsibility of a nominated Pharmacelsus project coordinator to ensure that all data is recorded appropriately. All study file entries are crosschecked and countersigned prior to data release.
How does Pharmacelsus ensure quality?
Unless otherwise agreed with the sponsor all assays are performed in accordance with the relevant Pharmacelsus Standard Operating Procedure (SOP). All assay details are recorded in study files.
Control compounds are included with each instance of an assay. The results of these controls must adhere to previously defined tolerance limits. If these data fall outside these limits the assay is repeated at Pharmacelsus’ expense.
All data manipulation and reports are independently checked for accuracy.
Is Pharmacelsus GLP certified?
Yes, since November 7th. 2008 Pharmacelsus has been included in the national GLP Compliance Program and is inspected on a regular basis.
The areas of expertise, according to OECD guidance are: (2) toxicity studies - (8) analytical and clinical chemistry testing - (9) other (pharmacodynamic, pharmacokinetic, metabolic and toxicological testing).
What are typical turnaround times?
As with any laboratory, there is a maximum number of assays or assay equivalents available, after which maximum capacity has been reached. Provided the sponsors screening demands do not exceed these, Pharmacelus will endeavour to ensure the turnaround times given in the description of the individual assays.
How are the data reported to the sponsor?
Results will be reported electronically as tabulated report (free of charge) or as agreed with the sponsor, as preliminary data containing the results obtained for test items and reference compounds in each of the assays tested and any comments relating to detection by mass spectrometry. The raw data can be supplied if required. It is the responsibility of a nominated Pharmacelsus project coordinator to ensure that all data is reported to the client within the agreed time frame.
What makes Pharmacelsus different from other CROs?
- Flexibility is our strength.
- Pharmacelsus not only offers you ready-made but also tailor-made Research Services, which only depend on your needs and our skills.
- Pharmacelsus does not simply provide you with results but will also give interpretations and recommendations on how to successfully proceed in your project.
- Independently of the size of your company or the number of your test items, Pharmacelsus will be proud to meet your requirements.
|
