Risk management, patient recruitment, data monitoring… We understand the challenges that your Phase II and III clinical trials present. With decades of experience, we can provide the services and solutions you need for your trial to succeed, whatever the therapy area, wherever in the world.
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.
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.
Clinical Monitoring to Ensure a Successful, Compliant and Safe Clinical Study
Our clinical monitoring services include study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse events reporting, regulatory compliance monitoring and regulatory documentation maintenance.
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.
Comprehensive Biostatistics and Statistical Programming Services
Our dedicated professionals include PhD and MS-level statisticians and statistical programmers located in North America, Europe and Asia, who adhere to a single set of global standards and manage various regulatory agency requirements. Our functional teams can also use our customers’ standard operating procedures if preferred.
Services include protocol development, including sample size and power calculations; randomization schedules; statistical analysis plans; statistical programming; statistical analyses using current methodologies; interpretation and reporting of data for clinical trial reports and publications; statistical and strategic consulting for product development; interim analysis for early decision making; database integration; adaptive design consulting and simulation support; data monitoring board management and support; NDA-ready data listings; CDISC-compliant datasets; and integrated safety and efficiency summaries.
Quality Interactive Response Technologies (IRT)
- 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.
We're Highly Experienced in Safety and Pharmacovigilance
We can provide integrated or stand-alone services to support compliant product safety monitoring both pre- and post-approval. Services include SAE monitoring and case processing, including case narratives; expedited report submissions in electronic and paper formats; periodic safety report preparation and submission; safety database management; and interim safety listings.
To assist during post-marketing surveillance, we can:
- Prepare/Submit
Individual case safety reports in MedWarch or CIOMS I formats; Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Event Reports (PADERs); Periodic Benefit Risk and Evaluation Reports (PBRERs); and expedited reports to global regulatory authorities.
- Provide
Standard operating procedures and work practices to manage pharmacovigilance activities; customized programs for managing spontaneous and solicited AE reports; EudraVigilance registration and testing and xEVMPD initial entries and updates; scientific literature reviews for identification of adverse events; litigation case processing; a global, multilingual call center; and case management support.
- Manage for Customers
Standard and non-standard/off-label medical inquiries from consumers and healthcare providers; product quality complaints; safety database, which supports both the Medical Dictionary for Regulatory Activities (MeDRA) and the World Health Organization (WHO) Drug Dictionary.
