Clinical Research
CCR Clinical Research Services
Experts in Clinical Research since 2011
Medical Scientific Consulting
CCR Medical Consultants are senior experts with long-standing experience in medical science and clinical drug development
- Medical Advisory
- Medical Writing & Scientific Research
- Medical Data Review
- Pharmacovigilance
- Drug Development Strategy
- Study Design and Concepts
- Development of Publication strategy & Writing Publications
- Patient Dossier Development
- Heath Technology Assessment
- Market Access
- DiGA Concept Development
Data Management & Statistics
CCR experts in Data Management & Statistics provide extensive analysis for:
- Clinical Study Statistical Evaluations
- Automation of Clinical Study data outcomes
- Regulatory Analyses in Validated SAS environment
- Biostatistics via BI Tools
- Predictive Analytics
- Data Maintenance via CCR Owned Servers
- Exploratory Analyses
- Clinical Study Trend Analyses
Additional Services
- Medical Support
- Development of Study Design, Clinical Trial Protocol, etc.
- Regulatory and KOL Support
- Medical Trends
- Medical Monitoring & Clinical Operations
- Development of Data Management Plan, eCRF, etc.
- Performing UAT and edit checks
- Drug Safety & PV
- Statistical Analyses Plan
- Query Management
- Creation of Clinical Study Reports, TFLs, etc.
- Project Management
- Patient Related Outcomes via Mobile Apps
- Regulatory Advisory and Communication
- Standardized Dataset Creation - SDTM, ADaM (CDISC)
- Data Integration and Exploratory Analyses
- Clinical Data Interactive Representation using BI Tools
- Study data management and review
- Data Trends and Predictions
Patient Related Outcomes (PRO)
CCR is deeply involved in development of electronic tools collecting patient reported data, and in trials using such of electronic patient reported outcomes (PRO). A PRO is directly reported by the patient without interpretation of the patient’s response by a clinician or anyone else and pertains to the patient’s health, quality of life, or functional status associated with health care or treatment. Patient’s opinion, patient’s impression and feedback are valuable and important as they might be significantly different from the one considered by the investigator or care provider physician.
According to current practice, capturing PROs is assisted by the investigator or the nurse, although this practice might influence patient’s opinion. Due to the assistance given to trial participants, a constant concern regarding bias surrounds these endpoints. Therefore, CCR is highly committed in creating “pure PRO” studies, where the patient has all the resources, and needs no input from the care provider to document his feedback.
Electronic tools, like mobile devices applications, are the basis for such “pure PRO” studies. By developing a user-friendly interface, and allowing the patient to document its data whenever and wherever appropriate, any external influencing effect can be excluded, and unbiased patient reported outcome can be captured.
Such an innovative approach is not just exciting but also challenging. Data protection, validation of electronic systems used to collect PRO data, data management and data cleaning are just some of the possible pitfalls.
Our committed team of clinical researchers, medical writers, data scientists and statisticians has the expertise to support you in overarching all these challenges, while our subcontractor company can build up the corresponding application. Once, everything is in place, a series of unavoidable benefits arise: cutting costs, improving compliance resulting in higher quality data, automated data management functions, real live analysis and visualization, etc.
Publications
Our Indication Landscape
Get in touch with us
We are happy to support you in your Healthcare data analytics and clinical research needs, contact us.
