CLINICAL SAMPLE KITS & MANAGEMENT SUPPORT
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www.altasciences.com CLINICAL SAMPLE KITS & MANAGEMENT SUPPORT Preparing, collecng and shipping clinical samples from trial sites to bioanalysis laboratories is a crical support service when managing clinical programs. Algorithme Pharma provides over 20 years of clinical research experience with a sample management team supporng clinical trials worldwide. Our shipper kits and manuals are customized to facilitate accurate collecon, storage and shipment of clinical samples. Shipper Kit SHIPPER KIT DESCRIPTION We have designed our kits to allow storage and shipping of different matrices such as plasma, urine, serum and whole blood. Our shipper kits can be adapted to specific study needs and com- monly include the following: Materials Tubes & Labels • Storage tubes and labels are provided in duplicate to allow clinical sites to retain an aliquot of each sample. • Draft label designs are pre-approved by the sponsor, and labels commonly include protocol identification, subject number, time, study day and date. • Labels are fixed on the tubes to allow the entry of information edits such as subject number, actual time and date of sample collection. Documents • The laboratory manual is customized to the study protocol and details specimen identification, sample processing and matrix collection methods. • Supporting services are included to ensure rapid transfer of samples through all aspects of shipping: Preparation, shipping instructions, and temperature log. Transfer Tubes (for Serum, Plasma, Whole Blood, Urine) • Pre-labelled vacutainer collection tubes for pharmacokinetic and / or pharmacodynamic samples with colour coded labels • Pre-labelled plasma screw cap storage tubes (colour coded labels) • Pre-labelled sample sorting and shipment flexible containers • Transfer pipettes • Safe needles • Disposable needle holders • Cotton balls and alcohol swabs
Transcript of CLINICAL SAMPLE KITS & MANAGEMENT SUPPORT
www.altasciences.com
CliniCal Sample KitS & management Support
Preparing, collecting and shipping clinical samples from trial sites to bioanalysis laboratories is a
critical support service when managing clinical programs. Algorithme Pharma provides over 20
years of clinical research experience with a sample management team supporting clinical trials
worldwide. Our shipper kits and manuals are customized to facilitate accurate collection, storage
and shipment of clinical samples.
Shipper Kit
Shipper Kit DeSCriptionWe have designed our kits to allow storage and shipping of different matrices such as plasma, urine, serum and whole blood. Our shipper kits can be adapted to specific study needs and com-monly include the following:
Materials
Tubes & Labels• Storagetubesandlabelsareprovidedinduplicatetoallowclinicalsitestoretainanaliquotofeachsample.
• Draftlabeldesignsarepre-approvedbythesponsor,andlabelscommonlyincludeprotocolidentification,subjectnumber,time,studydayanddate.
• Labelsarefixedonthetubestoallowtheentryofinformationeditssuchassubjectnumber,actualtimeanddateofsamplecollection.
Documents• Thelaboratorymanualiscustomizedtothestudyprotocolanddetailsspecimenidentification,sampleprocessingandmatrixcollectionmethods.
• Supportingservicesareincludedtoensurerapidtransferofsamplesthroughallaspectsofshipping:Preparation,shippinginstructions,andtemperaturelog.
Transfer Tubes (for Serum, Plasma, Whole Blood, Urine)
• Pre-labelledvacutainercollectiontubesforpharmacokineticand/orpharmacodynamicsampleswithcolourcodedlabels
• Pre-labelledplasmascrewcapstoragetubes(colourcodedlabels)
• Pre-labelledsamplesortingandshipmentflexiblecontainers
• Transferpipettes
• Safeneedles
• Disposableneedleholders
• Cottonballsandalcoholswabs
ALTASCIENCES COMPANY Inc.
www.altasciences.com
ALgOrIThME PhArMATel.: (450) 973-6077Toll free: [email protected]
www.algopharm.com
Sample management Support
To further support the management of study samples from international clinical sites, Algorithme Pharma offers a comprehensive Sample Handling Manual. This detailed manual includes a step-by-step sample handling description, tools to assess site capabilities, suggested sampling techniques and customized shipment instructions. Instruction Booklets can be requested in a number of different languages.
As part of an integrated service, technical support is provided to each clinical site to ensure there is centralized assistance for sample handling and shipment during the clinical program. For sample handling, training for the clinical site or monitors can be provided by our bioanaly tical scientists.
Take advantage of our sample management team’s expertise to simplify the collection, storage and shipment of your biological samples in global clinical trials. For more information on our Clincal Sample kits and Management Support, please contact us at [email protected]
