We customize our services to meet the needs of your Phase II and III clinical trials
The benefits of a clinical feasibility assessment
With regulatory authorities requiring more and more clinical data, increasingly complex protocols, and the challenges of enrolling patients and investigators, it’s vital that protocol and recruitment plans are evaluated early and carefully to avoid costly delays.
We can help you identify the best strategy to mitigate costs and risks, validate whether your protocol meets global requirements, and identify the best sites. We’ll also provide meaningful insight into your recruitment challenges, evaluate the impact of competitive trials, and optimize patient access and retention.
Identifying the right investigators and patients for your study
We have the database and site relationships to ensure rapid identification of potential investigators and their patient populations to help ensure enrollment goals are met. We can also train investigators and site staff on protocol requirements, best practices and technology tools, such as electronic data capture (EDC) and safety systems.
Additionally, we can monitor for compliance with the study plan, protocol and IRB review, and control of investigational products, as well as report safety data, inform sites about performance and contractual issues, and serve as a point of contact between site, sponsor, CRO and IRBs.
Successful patient enrollment, compliance and retention
By utilizing the most appropriate communication channels, dynamic patient education materials, loyalty programs, motivational tips, appreciation items related to the disease and reminders, we attract and retain broad pools of quality, prescreened patients.
We also offer a full suite of Bioanalytical Solutions for accurate, precise and timely data providing answers to your critical questions. Our wide range of experience means that we can bring multiple approaches to bear on addressing your method, development and validation needs.
Rapid, efficient trial execution
Our Global Study Start-Up (GSSU) team quickly identifies and activates qualified, credentialed and motivated sites. Each study has an experienced manager assigned to coordinate and facilitate start-up activities.
Your dedicated GSSU team can manage IRB/EC submissions, conduct informed consent reviews, take care of essential document collection and submission, deploy comprehensive metrics tracking benchmarks against projections, maintain post-start-up documents, manage translation, and coordinate site contracts and budgeting.
The team will monitor critical milestones and make sure that you have oversight of your clinical trial at all times so that you can track its progress.
Our medical writers provide clear, concise and professional presentation of study findings
Let our professional writers help you with regulatory writing, protocols and protocol amendments, informed consent forms/patient information leaflets, clinical study reports, subject narratives, investigator brochures, integrated summaries of safety/efficacy, literature summaries, clinical expert reports, INDs, NDAs, BLAs, CTAs (Module 2) summary documents, IND and NDA annual reports, safety aggregate reports (PSURs, PADERS, line listings, DSURs), and clinical trial registry synopses.
An innovative approach to clinical data management shaped by our industry experience
We can guide you on the most appropriate method for data collection to best serve the needs of study sites and project teams. Our data management services include Case Report Form (CRF)/eCRF design; database design and implementation; data validation, review and cleaning; medical coding; data management processes inspected by an independent quality control team; comprehensive management of data from third-party electronic data vendors; data consolidation, migration and conversion, including CDISC SDTM transformations; study rescue services; consultation and data management strategies, systems, procedures and metrics; and flexible staffing.
• Inventory Management Services
These include drug supply ordering and tracking; shipments to sites/depots; predictive, target threshold and just-in-time supply models; drug expiration date management; multi-study supply pooling; and low inventory alerts.
• Randomization Services
Services include static and dynamic randomization schemes, stratification and cohorts; adaptive trial designs; parallel and cross-over trials; variable dosing and titration; automatic randomization limit alerts; multilingual telephone voice prompts and technical support; emergency unblinding service for authorized individuals; and critical conditions and milestone achievement alerts.
• Real-time Web Reporting
These include interactive web reports for subject and inventory information; downloadable web reports in various formats; blinded and unblended configured reports; and transaction data capture on confirmation reports.
• eDiary Services
Services include patient-reported outcomes capture; automatic eDiary compliance alerts; and real-time reporting of patient-reported outcomes.
• IRT Service Options
Options include integration with electronic data capture (EDC) systems; custom integrations with CTMS, ePRO and other systems; and site activation with optional IRB data capture and extension rules.