Clinical Trial Services

Wimmer Clinical provides management and monitoring of clinical trials in strict accordance with ICH GCP guidelines, FDA regulations, sponsor SOPs, and the study protocol. We can provide full support of clinical operations management to get your trial started, or just emergency monitoring coverage.

Monitoring services

· Pre-Qualification, Initiation, Interim, and Close-out Visits

· Investigator payment request and reconciliation

· Laboratory invoicing and reconciliation

· Ensuring Schedule II and III investigational product is shipped, stored, accounted for, and dispensed according to Federal and State Regulations

Support services for CRA management

· Training and management of contract CRAs

· Mentoring of new full-time CRAs

· Review of trip reports

· Preparation of source documents and newsletters for clinical sites

· Preparation of monitoring tools for CRAs

· Consultation and review of protocols and CRFs for new studies

Project Management

· Proposal preparation and defense

· Contract negotiation

· Project/Operations Management

· Investigator Meetings

Experience

A sampling of the trials we've been involved with are listed below:

Adult

· Oncology: Relapsed Refractory NSCLC, Follicular Lymphoma, Myelodysplastic Syndrome w/anemia and/or thrombocytopenia; Colorectal, Non-Small Cell Lung, Renal Cell Carcinoma, Stage IV Melanoma, Leukemia, Bladder, Head and Neck, Glioblastoma, Breast, Anemia of Cancer

· CNS: Pain Management (Post-Surgical (Arthroscopic Knee Surgery and General Surgery), Osteoarthritis, Low Back Pain and Carpal Tunnel Syndrome); Alzheimer’s Disease, ADHD

· Cardiovascular: Stroke, Atrial Fibrillation, DVT, Hypertension

· Metabolic: Hypogonadism in Erectile Dysfunction; Hypercholesterolemia

· Infectious Disease: Community-Acquired Pneumonia

· Immunology: Asthma, Allergy, Lupus , Hereditary Angioedema

· Women’s Health: Postmenopausal Osteoporosis

· Endocrinology: Diabetes (Project and Data Management only)

· Urology: Irritable Bowel Syndrome, Urgency, Incontinence

Pediatric

· CNS: ADHD (Phase IV), Multiple Sclerosis (RRMS - retrospective data collection)

· Autism

Medical Device

· Cardiovascular (platelet assay)