Clinical Development Services
The foundation for excellence in clinical research
Whether you are in need of one or more specific capabilities or seeking a strategic functional service provider (FSP) partnership, we can help.
Across a full range of clinical development services, we offer the deep expertise, operational excellence and advanced technologies you need to navigate the complexities of today’s clinical trial environment.
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Biostatistics & Statistical Programming Services
Whether it’s a small first-in-human exploration or an international clinical trial, our global Biostatistics and Clinical Programming services team brings technical expertise and efficiencies to projects of all sizes, through all phases of clinical development and commercialization.
Accuracy when it counts – which means always
Our standardized processes, validated technologies and experienced staff prepare tables, figures and listing outputs in advance of database lock, helping you make swift internal decisions and communicate effectively with the public, partners and/or investors.
Offering analysis and reporting services to meet every need, including:
- High-end statistical consulting
- Comprehensive statistical analysis plans (SAPs)
- Randomization schedules produced in accordance with Integrated Response Technology (IRT) requirements
- Submission-ready datasets and supporting metadata, consistent with industry standards and trends
- Blinded and unblinded (e.g., interim and DMC analyses) Tables, Listings and Figures (TLFs), stand-alone statistical reports
Clinical Data Management Services
Combining the latest technologies with years of data management experience, our global Clinical Data Management services team adopts an intelligent approach to developing and implementing quality data collection solutions. With a focus on a streamlined, effective route to database lock, we utilize a suite of techniques to identify and resolve data discrepancies and assure data quality.
We strive for real time readiness and believe in data transparency
We use novel approaches and tools to monitor and report on data quality and progress and keep our customers up to date with performance throughout the project. Quality and risk management are embedded are every step to facilitate early risk/issue detection, feed vital information to the project team and provide an adaptive approach to monitoring and trial delivery.
Industry-leading EDC solutions and technology innovation
We specialize in customized solutions to accommodate project-based or flexible functional service provider models. Our teams are proficient in all the top industry clinical database systems, and we have been running EDC studies for more than 15 years, with over 1,700 studies completed or in progress.
Clinical Monitoring Services
A clinical trial has many complex, moving parts and each must be monitored to protect the safety of study participants and data integrity while keeping the study running according to protocol and regulatory requirements.
Streamlining strategy to mitigate risks and drive data integrity in clinical trial monitoring
We take a risked-based monitoring (RBM) approach to developing and executing monitoring strategy, using comprehensive dashboards customized to the specific risks of each trial.
Orchestrated by the clinical trial manager, our highly-skilled central monitors (CTs) and clinical research associates (CRAs) collaborate closely and work in sync along with our risk managers and RBM subject matter experts to resolve concerns swiftly so that patients stay safe, studies stay on schedule and results remain robust.
The result?
• Issues are detected 20% faster than by traditional monitoring methods
• 40% of queries and protocol deviations are detected by our CMs so that CRAs can focus on taking corrective actions with sites
Developing new clinical talent
Our Clinical Monitoring team members perform crucial roles in patient safety, site and study compliance and clinical data integrity. Staffing and consistency in these roles are paramount to project success. Our Clinical Training Institute and Oncology Academy, accredited by the International Accrediting Organization for Clinical Research (IAOCR) helps us maintain a talent pool of CRAs focused on high-quality project delivery. We’re building better CRA teams with first-in-industry immersive virtual workforce training.
Medical Writing Services
Our medical writing expertise spans a broad range of therapeutic areas and document types, from preclinical reporting through the drug development continuum to post-marketing and commercialization writing. Our services include:
- Protocols and amendments
- Investigational medicinal product dossiers (IMPDs)
- Informed consent forms and patient information leaflets
- Clinical study reports (full, abbreviated, interim, and synoptic)
- Patient-level and event-level safety narratives
- Annual reports
- Briefing documents
- Investigators’ brochures
- Investigational new drug applications (INDs), new drug applications (NDAs), and common technical document (CTD) submission dossiers
- Regulatory responses
- Risk profiles
- Periodic safety update reports (PSURs)
- Periodic benefit-risk evaluation reports (PBRERs)
- US Food and Drug Administration periodic line listings
- Risk management plans (RMPs)
- Development safety update reports (DSURs)
- Local safety summaries (LSSs)
- Signal analyses
- Clinical overviews
- Medical publications writing
- Assistance with publication planning and journal submission
- Literature reviews and searches
- Oral presentations, posters, and abstracts
- Slide kits
- Medical information letters
- Advisory committee slide creation
- Submission support
- Document project management
- Regulatory document finalization and publishing
- Clinical trial transparency and disclosure
- Lay language documents
- Document redaction
- Clinical trial registry records support
- Regulatory submission bibliographies
Trial Master File (TMF) Operations
Clinical trials can be large and complex, involving many departments and partners. As a result, Trial Master File (TMF) management can become a difficult task. We are a specialist provider of technology-enabled eTMF solutions and other support services for the global clinical research market.
Our skilled, dedicated team manages the TMF process with a focus on quality and compliance, and we’re here to help ensure success for your trial. Timely, thorough and accurate processing of TMF documents is among the most important services we provide. Our services include:
- TMF completeness reviews
- TMF inspection readiness evaluations
- TMF migration planning/remediation
- TMF transition/conversion
- TMF consultancy services
- Document processing services
- TMF management services
Rater Training Services
Our Rater Training specialists work to improve the quality and consistency of test administration and test scoring/behavioral rating of scales so our customers can see an improvement in the quality and consistency of their data.
Our team members are highly experienced clinical psychologists, neuropsychologists, psychometrists and assessment specialists who have extensive global experience in providing rater training. They provide expert, comprehensive rater evaluation, rater training and rater scales management services coupled with unparalleled scientific, technical and procedural support.
Look to us as the definitive source for rater training, rater evaluations (Central Rating Review), document management (translations, harmonization, copyrights, workbooks) and computerized neuropsychological assessment in multi-center clinical trials.
Clinical Trial Investigator Management Services
We are dedicated to ensuring our customers obtain the quality clinical research data they need to get medical treatments to patients sooner. To do this it’s essential that clinical trial principal investigators and sites are happy with the clinical trial payment process and we achieve this through automation, industry-leading transparency reporting capabilities, and integrated data management and site contracting. We remove pain points by:
- Assigning a dedicated, single point of contact at the CRO or sponsor to handle financial matters
- Communicating the payment escalation process at the beginning of each study
- Making sure sites receive monthly clinical trial payment
- Making the process simple, fast, transparent and efficient through use of our proprietary online tool
- Providing top-line simultaneous notification of payments received and pending for speedier and more efficient reconciliation
- Reducing the number of invoices that sites are required to generate and removing holdback clauses wherever possible
Learn more about what we offer and how we partner.
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