Our Serviceswe care for you
What we do
Measurements and data analysis of functional explorations
- Quantitative and qualitative analysis of Sleep, EEG, local sleep (256 electrodes); EEG power spectrum
- Subjective and objective evaluations of sleepiness and vigilance
- Specific evaluation of sleepdisorders
- Mood, cognitive and neuropsychiatric evaluations
- Measures of various parameters with circadian rhythmicity: melatonin (phase, amplitude, suppression by light) in blood, saliva and urine; other endocrine rhythms (cortisol, TSH..); core body temperature, variables of the autonomous nervous system through EKG, blood pressure monitoring and specific data analyses
- Biological evaluation of wake promoting systems: CSF hypocretin and histamin assessments
- Studies of the endogenous clock through genetic tools on cell culture Genetics: Genotyping (PER3 genotype, HLA typing …)
- Banking: Genomic DNA (GWS – LSS), serum, saliva, CSF
- Ongoing project for sleep data collection and analyses: (high density EEG, possibility to fusion with MRI and fMRI)
Project and Clinical Data Managment
Under the Project and Clinical Data Management offering, we provide Clinical Data Management services in a wide range of study designs and methods. We provide services from the design of the Case Report Form, database build, testing and validation, data entry, coding and Serious Adverse Event (SAE) management, to delivery of complete and accurate data in a customized output format.
Our Clinical Data Management team offers tailored concepts across all key therapeutic areas with particular expertise not only in pivotal Phase II/III trials, but also for late-phase approaches. We combine experience with technology and therapeutic expertise to ensure actionable outcomes and highest quality and process acceptance in terms of the data we deliver.
Regardless which Data Management or EDC system you are using, we can build Clinical Studies for you, including:
- Definition of the Global Library
- Definition of Data Extracts
- Creation of Data Collection Modules
- Migration of data to other systems
- Creation and testing of Edit checks
- System Configuration & User Access
- Batch Data Load of external data
- Coding Dictionary Setup
We can develop your standard reports or Study specific queries for your Data Management database.
Freelance Clinical Research Associate
Monitoring activities conducted by Clinical Cert Clinical Research Associates (CRA) are regarded as one of the most important part in the conduct of a new drug development.
Our CRAs are skilled and well trained to ensure a highest quality review of your study data and to interact effectively with the study sites.
Being the main communication link between site and study sponsor the main tasks of Clinical Cert CRAs during a clinical study site visit are:
- Establishing a clear, individual and well-structured communication to the site
- Ensuring the regulatory compliance of study sites.
- Overseeing the process of data collection
- Verification of source documents and case report forms
- Resolving of queries
Consultancy, Training ICH-GCP Certification
ICH-GCP training and Certification for Investigators and study site research personnel. The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants.
The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.A, EUROPE and ASIA.
• Institutional Review Boards
• Informed Consent
• Confidentiality & Privacy
• Participant Safety & Adverse Events
• Quality Assurance
• The Research Protocol
• Documentation & Record-Keeping
• Research Misconduct
• Roles & Responsibilities
• Recruitment & Retention
• Investigational New Drugs
Research professionals are required to complete a quiz following each module, except for the Introduction module. To receive a certificate, all quizzes must be completed with at least 80% accuracy. Upon successful completion of all quizzes, the user will be given access to the Certificate of Completion.