Clinical Research
From early-stage innovations to post-market approval, our full-service contract research organization (CRO) division is dedicated to delivering excellence in clinical research to life sciences, biotech and medical device companies.
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
- Site payments
- Organization of investigator meetings and site training
- Electronic trial master file (eTMF) 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
- Site engagement
Clinical Monitoring
Our clinical research associates (CRAs) 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 visits
- Remote monitoring
- Site personnel training, mentoring and guidance
- Assessing protocol compliance and data integrity
- Issue management and escalation
- Regulatory document review
- Pharmacy training and IP 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
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
- Protocol development support
- Providing input into CRF design and annotations
- Statistical analysis plan
- Randomization list development
- Randomization and unblinding 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
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
- Quality management system
- Inspection readiness support
- Training
Medical and Scientific Writing
Our experienced medical writers deliver exceptional quality across a wide range of subject matter. We provide our clients with the highest scientific standards that meet all international guidelines and regulations.
Services include the development of:
- Comprehensive literature reviews
- Systematic reviews
- Clinical regulatory module preparation
- Phase I-IV study protocols
- Investigational drug brochures
- Clinical study reports and safety narratives
- Peer-reviewed original manuscripts and review papers
- Presentation posters and abstracts
- Technical briefs
- Training manuals
Medical Monitoring and Drug Safety
We understand the importance of ensuring drug safety and minimizing risks associated with the use of medication. Our pharmacovigilance services are designed to help our clients comply with regulatory requirements, identify and assess potential safety concerns, and monitor adverse events related to their products.
Medical monitors support our study teams with:
- Project-specific training
- Input on protocols, investigator brochures, informed consent forms, case report forms, data management and validation plans
- Development of the safety management plan
- Serious adverse event (SAE) Management
- Medical coding review
- Safety reviews
- 24/7 medical oversight
Data and Safety Monitoring Board
A data and safety monitoring board (DSMB) is an independent group of experts that objectively reviews trials on an ongoing basis to ensure the safety of study subjects and the validity and integrity of the data.
Services include:
- Developing DSMB charter
- Identifying and contracting with DSMB members
- Monitoring conflict of interest and financial disclosure for DSMB members
- Preparing DSMB meetings (e.g. scheduling, generation and validation of applicable tables, listings and figures)
- DSMB meeting execution and follow-up (including communication with sponsor, ethics and regulatory bodies, as per the DSMB Charter).
Regulatory Affairs
Regulatory affairs consultants provide regulatory and product feasibility advice on the development and commercial production of therapeutic, biologic and device products.
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.
