Contract Research Organization (CRO) Services
Calian has more than 20 years of experience providing high-quality clinical research services to companies with early-stage to post-market approval products. We are focused on quality and customer success.
Functional Service Provider (FSP) Solutions
Our comprehensive functional service provider (FSP) solutions help pharmaceutical, biotech and medical device companies deliver innovative products that make a difference.
We can help you find the right people to make your study or project successful, including:
- Clinical study/project managers
- Research associates/coordinators/budget specialists
- Medical information/scientific communication specialists
- Pharmacovigilance/technical complaints specialists
- Medical operations leads/coordinators/specialists
- Regulatory affairs associates/coordinators/specialists
- Quality assurance/auditors
Whether you need temporary, short-term or long-term resources, we can customize a solution to optimize your budget and schedule.
Clinical Study Management
Study management is critical to the success of every project. Our experienced professionals deliver superior service by taking a collaborative approach to study management. This approach, combined with exceptional organizational and interpersonal skills, creates a responsive, client-driven environment.
Services include:
- Site selection and feasibility assessments
- Study start-up and pro-active study planning
- Risk management
- Collaborative interaction with regulatory authorities and ethics committees
- Site contract and budget preparation, negotiation, and administration
- Organization of investigator meetings and site training
- Electronic trial master file management
- Recruitment and retention support
- Drug safety/pharmacovigilance
- Data safety monitoring board support
- Coordination of site/vendor/client communications
- Study budget management and forecasting
- Tracking project performance metrics to ensure deadlines are met
Clinical Monitoring
Our clinical research associates are known for their outstanding client service, attention to detail and in-depth knowledge of industry regulations and guidelines. They verify compliance with protocols, quality standards, data collection and regulatory guidelines–ensuring the highest quality data for your clinical trial.
Services include:
- Site selection, initiation, interim monitoring, and close-out
- Remote monitoring
- Site personnel training, mentoring, and guidance
- Assessing protocol compliance and data integrity
- Regulatory document review
- Pharmacy training and drug accountability
- Ensuring adherence to GCP, regulatory, confidentiality, and safety requirements
- Support audit/inspection readiness
Data Management
We offer a full spectrum of data management services and expertise to optimize your data. Our clinical data managers rigorously follow standard operating procedures that encompass security, industry regulations and ICH/GCP. They work collaboratively and cross-functionally to ensure all stakeholders needs are met. We use a comprehensive, but easy-to-use, cloud-based clinical data management platform that supports a wide range of study types and designs.
Services include:
- Data management planning
- CRF and database design
- Quick EDC database build and validation
- EDC functionality, including:
- ePRO
- Medical coding using MedDRA and WHODrug
- Lab normals
- Targeted SDV
- Reporting dashboard with real-time access to datasets on demand
- Role-based security and access control
- End-user training, including CRF completion guidelines
- Third-party data import
- Ongoing data cleaning and query management
- Clinical trial safety database/reconciliation
- Database lock activities and archiving
Quality Assurance
Our quality assurance team provides compliance oversight and guidance through carefully planned audits and detailed reports. This allows continuous process improvement to ensure the ongoing effectiveness of your clinical trial.
We also offer quality assurance services that are independent audits of clinical investigational sites, processes, documentation and assessment of the quality of the data collected and processed.
Services include:
Evaluation and auditing of GCP Quality Processes
- Vendor qualification and due diligence audits
- Investigator site audits
- Data management process audits
- Clinical study report and regulatory submission document audits
- Systems and process audits
- Pharmacovigilance and drug safety reporting
- Computer system validation documentation compliance
- Clinical research operations
- Standard operating procedure (SOP) and policies development
Monitor Assessment Program (MAP)™ Audit Services
- Real-world assessment of CRAs/contract CRAs
- Objective feedback for improvement areas
Infusion Clinic Evaluation (ICE)™ Services
- Detailed formal evaluation
- Practice/health system organization standards and regulatory guidelines alignment
Biostatistics
Biostatistical design and analysis are central elements of any clinical trial. Establishing a sound biostatistical plan results in optimal study design and high-quality data output. Comprehensive statistical input during the early stages of a clinical development program decreases overall costs and accelerates timelines to regulatory approval.
Services include:
- Sample size calculation
- Randomization list
- Protocol development support
- Providing input into CRF design and annotations
- Statistical analysis plan
- SAS programming and validation of tables, listings and figures
- Interim and final data analysis
- Supporting medical writers with abstracts, manuscripts, posters and final clinical study reports
- Database lock and archiving procedures
- Data safety
Decentralized Clinical Trial Solutions
Our decentralized clinical trial services are patient-centric and designed to improve the patient’s experience, which leads to better patient engagement and increased retention rates. We make it easy for patients to participate, by bringing trial activities to them wherever they are located: home, work or in-clinic. This allows us to reach a larger, more diverse pool of patients for your clinical trial.
