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Neuroscience is one of the key therapeutic areas with continuing medical need and one with many compounds in the research pipeline. Premier Research's expertise is therefore focused on bringing these compounds through the clinical development process as quickly and efficiently as possible, while maximizing the value of the data and information produced.
The study of CNS conditions can present a myriad of challenging situations throughout a clinical trial. You need a team of clinical research professionals who understand the complexities of studying and treating patients suffering from these disorders. The concentration of resources and dedication of staff with a focus in neuroscience research, Premier Research offers a depth of experience that only a therapeutically focused CRO can offer.
In addition to our comprehensive selection of services, we own and operate dedicated specialty research clinics equipped with quiet psychometry suites for your CNS clinical trial needs.
- Neurological Disorders
- Psychiatric Disorders
Proven Experience
Premier Research understands the key methodologies relevant to neurological indications and the critical success factors needed for each indication, including careful selection of sites. Having conducted more than 80 clinical trials and 15 consulting projects in neurology in the past five years, Premier Research is able to help you to design the optimum clinical development plan and implement that plan in the most efficient and cost-effective manner.
Premier Research recognizes that there are many factors that influence psychiatric clinical research, including patient assessment, placebo response analysis, investigator interactions and inter-rater reliability. Having conducted more than 25 clinical trials and five consulting projects in psychiatry in the past five years, Premier Research understands these issues and effectively designs and manages psychiatric clinical trials with these in mind.
Premier Research recognizes that the field of neuroscience is rapidly changing with innovative neuro-imaging techniques and breakthroughs in molecular biology that are ultimately expected to benefit both patients and their families but present substantial clinical and operational challenges for drug development programs in the neurosciences. Complex issues such as drug target validation and drug delivery to the central nervous system with novel delivery systems can complicate early clinical trials and must be critically evaluated to insure optimization of clinical trial design.
We realize that the success of clinical trials in neuroscience is dependent on a seamless interaction between sponsor, CRO, and investigational sites. Such studies require a thorough understanding of study design and methodology, knowledge of the use and limitations of biologic surrogate endpoints, understanding of the complexity of patient assessment tools, as well as awareness of investigator and patient needs. Successful execution of a well-designed study also requires an experienced team. Our neuroscience experts draw upon years of experience managing clinical trials and relationships with networks of investigators with proven track records for subject recruitment and quality data. Our experts select the investigators and study site that are best-suited to meet the goals of each study and the objectives of the sponsor. Our teams are committed to efficient, effective study execution and meticulous monitoring.
Despite the evolution of novel neuro-imaging and use of biologic surrogate endpoints in clinical trials in diseases of the CNS, the use of investigator and patient rating scales still remain the most commonly employed efficacy measures in these trials. The challenge presented by these scales must be understood including differences in reporting outcomes with multiple observers, the need for standardization in a global research environment, and sensitivity to cultural differences that may affect outcomes. Practical considerations such as appropriate rater training are key to the success of the trial and must be clearly defined.
Premier Research has years of clinical trial expertise utilizing a range of clinical assessment tools or scales performed by the patient, caregiver, and clinical personnel including but not limited to: - Assessment of Disability Scales or Health Status Scales
- Disease Specific Quality of Life Questionnaires
- Clinical Global Impression Scales
- Global Assessment of Functioning (GAF) Scales
- Side Effect Scales
- Scales Assessing Personality Dimensions
- Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
The IVRS/IWRS technology used by Premier Research helps to address the challenges presented by rating scales for subjects in clinical trials. The technology allows subjects to enter their self assessments in a user friendly manner by simple phone script entry or web-based entry.
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