Profile

Additions

Advanced Services

CRP provide monitoring services, project management for national and international Phase I-IV clinical trials. The services are as follows:

Feasibilities
Development of all trial related documents
Investigators recruitment
Investigator Selection Visits
Prestudy- and Initiation Visits
Study specific training for Investigators

Support for investigators meeting
Risk Based Monitoring
Status reports
Project Management for small to mid-size clinical trials (regional PM)
Study Close-Out activities

Since 2010 CRP provide services for Quality Assurance and Quality Control as follows:

Planning, performing and follow up of GCP, GCLP audits, including vendor qualification/requalification assessments, TMF/eTMF audits
CAPA Management
Performing mock-inspections, preparing and participating EMA, FDA, EMA, PMDA inspections
SOP Review
Co-Monitoring, CRA and site staff training on GCP

Meanwhile 25 years of experience in clinical trials ensures that clients receive the best possible services and with all the applicable regulations and guidelines (e.g. ICH-GCP, FDA, J-GCP, AMG, etc.)

Clients

Therapeutic Expertise

Gastroenterology

Morbus Crohn, Colitis Ulcerous

Dermatology

Dermatitis, Psoriasis, Neurodermitis

Ophthalmology

Allergic conjunctivitis, Rhinitis

Diabetes Mellitus

Type I/II, Insulin pump

Metabolic Disease

Urology

Cystitis

Pneumology

Chronic bronchitis

Oncology & Radiology

Mama-carcinoma, Leukemia (CLL, AML)

Neuro-Oncology

Anaplastic astrocytoma

Cardiology

Atrial fibrillation, Myocardial infarction, Coronary heart disease

Nephrology

Chronic kidney insufficiency, Hyperparathyroidism of ESRD

Neurology

Migraine, Epilepsy, Overactive bladder

Orthopedic

Osteoarthritis and rheumatoid arthritis

Postmenopausal Osteoporosis

Therapeutic Expertise