Clinical Data Management Services
OUR BIOMETRICS CAPABILITIES:
Our Biometrics team is always eager to help you improving efficiency, significantly reduce development costs, and anticipate any risks upfront for clinical trial data.
Our Biometrics division can offer different services:
- Clinical Data Management.
- Statistical Programming and Biostatistics
- Medical Writing
Clinical Data Management
We provide end to end data management services from Study start-up to Study closeout, our experienced Clinical Data Management (CDM) team analyse the data collection requirements from Sponsor, implements different effective strategies, and thereby provides the tailor-made solution which is quick, reliable and cost-effective. The team has rich experience in handling various industry benchmark EDC tools such as Inform, other tools
- Design Case Report Form (CRF) & Review
- CRF and data query tracking systems
- Database setup / Design and Validation
- Data Management Plan
- Data Cleaning and Reconciliation
- Medical Coding Services; Coding in Med DRA & AC check
- Overall Study Management
- Data processing; Remote Data entry & double Data entry
- Coding of diagnoses, AEs, and drugs
- Adverse event coding
- Database lock and archiving
Our Clinical trial Data management services include:
- Quality Assurance
- Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.
- Clinical Development
- Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.
- Bio Analytical
- ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.
- Project Management
- ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.
- Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.