CCDRD delivers a high level of central laboratory and data management services to our customers - suited for multinational clinical trials. Our approach to providing complete, accurate, submission-quality data for your clinical trial includes:

A kit-specimen accessioning process that goes beyond custom, visit-specific kits and requisitions, positively accounting for all specimens received or expected in each protocol-specific kit

• Specimen validation that includes stability (time), condition (temperature, broken containers), specimen identification, and correct container or specimen type
• Check of appropriate specimen volumes for testing and retesting (if necessary)
• Raw data (requisitions, laboratory instrument printouts, laboratory information system worksheets, project files, and documentation for software change control and validation) will be stored for 15 years after the end of the study

To date, CCDRD has serviced more than 7,000 investigator sites from Ireland to Bulgaria, and Sweden to South Africa. We work actively with more than 100 sites every month. We take pride in our commitment to servicing investigator sites in every aspect of clinical trial: laboratory data collection, shipping, and reporting, assuring that our communication and support processes achieve the highest level of consistent quality.

Knowing that training is an important key to the success of your study, CCDRD offers extensive training for personell involved in clinical trials from the beginning of the study through its completion.

Visit-specific kits and requisitions are customized for your protocol:

• Contain supplies the sites will need for collection and shipment of  specimens: test tubes, pipettes, syringes, and other required materials
• Include instructions for collection and shipping
• Provide visit-specific reminders for investigators
• Validate dosing information to ensure compliance

Our unique tracking system establishes an audit trail once we ship pre-identified kits to the investigator. The tracking system continues at the investigator site to ensure that specimens are correctly drawn and identified.

We provide:

• consistent methodologies for the life of the drug development process
• clinical trial reference ranges specific for clinical trials patients
• protocol-specific result flagging
• a commitment to using consistent standard operating procedures, methodologies, reagents, calibrators, and whenever possible, controls

Because of our broad, on-site testing capabilities, CCDRD AG offers faster turnaround for particular analytes. We offer microbiology, flow cytometry, genomics and specialized testing services, we can easily accommodate new technologies and work with clients to achieve their testing protocol needs.

CCDRD AG provides uniformity of the technical database worldwide, data combinability through test correlations, and statistical evaluation of accuracy and precision.

Clients trust CCDRD AG to listen to their needs, understand their strategy and objectives, and work diligently to shape the appropriate solution. With combined clinical trial experience - and using the industry's most advanced technology - our properly trained, educated staff is well qualified to provide consultative services and to design and implement studies in ways that provide consistency, accuracy, and precision for your data.

To minimize your burden of responsibility and ensure that your contract laboratory is in compliance with regulatory agencies, we follow strict regulatory guidelines. You can be assured of the integrity of your data, because our audit trail requirements are incorporated in routine day-to-day operational processes. Our quality assurance program controls and continually updates its standard operating procedures. At CCDRD, our quality assurance methods and activities are continually adapted to changing regulatory and pharmaceutical industry requirements to facilitate your NDA approval.

If pharmacokinetics testing is required, our facilities in Europe can shorten your turnaround times and lower your costs by receiving the shipments directly from the sites, and electronically providing the results so that you can evaluate them faster.

		Top

We have successfully developed a cross-center validation method for DXA (dual-X-ray-absorptiometry) as required by FDA and EMEA for comparing results of bone densitometry. The most recent project involved about 20 sites using different makes, models and software-versions of DXA equipment.

		Top

CCDRD Central Diagnostics was established in 1993 and focused on 24h Blood Pressure Monitoring and long-term electrocardiogram.

In the meantime we are open for any customized solution and provide databases with online access for our customers. On request we can offer a staff cardiologist who is available around the clock. Toll-free numbers can be opened for ECG transmission.

CCDRD Investigator Services are available to you throughout the study to assist you with equipment, supplies and questions about specific patient blood pressure and ECGs. All aspects of your study will be treated with prompt assistance.

		Top

• Diagnostic cytopathology
• Tissue pathology
• Immunohistochemistry for oncology trial screening

We offer to you a full coverage of specimen transportation control and online recording.

CCDRD AG will:

• Retrieve and send specimens and additional items anywhere in the world
• Store samples at ambient conditions, -20^oC, -70^oC, -80^oC, or -150^oC
• Record all specimen movement or changes
• Report on the status and location of any specimen at any given time
• Merge all results collected (including referral laboratories) into standard CCDRD data transmissions

CCDRD Central Laboratory's paper (or hard-copy) reporting system offers clients flexibility in customization while meeting their protocol-specific needs. For most analytes, we deliver hard copy reports to investigator sites within 48 hours of the patient visit. Based on clients' protocol needs and budgetary considerations, we also have the capacity to fax reports to clients or investigator sites within 24 hours of the patient visit.

All of our hard copy patient laboratory reports:

• Include patient demographic data
• Contain the clinical trial reference range associated with each analyte
• Contain specimen collection information
• Include additional patient or administrative information collected on the requisition, if requested by clients
• May be designed to prompt the investigator for signature and comments
• May be written to allow clients to define flagging terminology
• May be customized to match clients' case report form format
• May be delivered on a scheduled day of the week that best suits your schedule
• May be sorted in the order of investigator and patient to facilitate review
• Can be offered as a laboratory cumulative report

Patient laboratory reports can be delivered any way you want:

• autofaxed
• daily courier
• presorted by investigator or project
• scheduled for your specified frequency

In addition to patient laboratory reports, other enrolment and abnormality reports can be provided.

		Top