Our Commitment to Exceptional Service

We understand that our success depends on your success. That’s why you can count on CEDRA for meticulous care and attention to detail every step of the way. Our broad range of services is designed to help achieve your drug development goals efficiently and cost effectively.

CEDRA offers a full range of Phase I-IV clinical research and bioanalytical services, as well as specialized studies to determine the effects of dose, formulation, dosing regimen, drug interactions, genotype, gender, and other factors on pharmacokinetics. We provide expert advice on everything from protocol development to regulatory submission.

Preclinical, Clinical and Global Trials

CEDRA’s combination of a state-of-the-art bioanalytical lab, in addition to clinical research sites, means we are ready to play an important role in your drug development program, from preclinical and toxicokinetic analyses to later-phase clinical trials involving any number of patients at sites around the world.

CEDRA’s two modern clinical research facilities in Austin (100 beds) and San Antonio (250 beds), Texas, offer a full range of services, including pharmacokinetic and pharmacokinetic/pharmacodynamic modeling; bioequivalence and bioavailability testing; and clinical and preclinical pharmacokinetics/toxicokinetics. When your trials require a global reach, CEDRA works through our parent corporation, WCT, a leading provider of international contract clinical research services.

Bioanalytical

At the backbone of our analytical capabilities is experience stretching back to 1990 and a library of more than 1,400 validated methods. Our laboratories are fully GLP-compliant, and are committed to quality and accuracy, even on high-volume, fast turnaround projects. With extensive use of laboratory automation and numerous LC/MS/MS instruments dedicated to sample analysis, CEDRA can analyze approximately 50,000 samples per month to help you meet your deadlines.

Our Ligand Binding Assay (LBA) laboratory complements our small molecule bioanalysis, pharmacokinetic modeling, and clinical trial management services. The ligand binding technique allows us to support preclinical and clinical studies, including biomarker and immunogenicity studies, as well as method development, optimization and transfer in both healthy volunteers and various patient populations, such as those with neurologic and psychiatric disorders.

Specialized Studies

Our new Specialized Studies Unit in San Antonio provides access to healthy norm participants, as well as special patient populations such as Alzheimer’s, MCI, schizophrenia, depression, anxiety, cardiovascular, asthma, SAR and ophthalmologic patients. In addition, we provide you access to experienced staff with expertise in specialized procedures such as computerized and standard cognitive testing, challenge studies, imaging studies (PET, DWI, FLAIR and MRI/fMRI), various surrogate biomarkers and specialized clinical efficacy assessment studies.

CEDRA conducts highly specialized studies requiring state-of-the-art techniques, staffing, equipment and facilities. Among these are:

• Maximum Tolerated Dose (MTD) (Bridging) studies define the tolerable dose range early in the development process, allowing confidence in knowing the common AE profile and highest tolerable dose that can be used in Phase II.
• Cerebrospinal Fluid (CSF) Dynabridging studies employ discreet and continuous time point collections to confirm brain penetration of psychotropic agents, their PK profile in the brain, and action on neurotransmitters and/or other strategic biomarkers.
• Rescue and complex studies that have faltered on enrollment or procedural expertise.
• Specialized later phase studies that require inpatient monitoring.
• Thorough QTc studies are conducted with state-of-the-art Mortara telemetry equipment and capability for data reading and transmission to your specifications.

In addition to full time physicians who specialize in internal medicine and pulmonary/critical care medicine, our medical consultants specialize in neurology, psychiatry, cardiology, ophthalmology and anesthesiology. At CEDRA, we take full advantage of scientific and medical expertise from WCT in areas of psychiatry, neurology, analgesia and cardiovascular medicine.

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