- Europe, North America, …
- United States, South Korea, …
- Human Medicines, Generics, …
- Service category
- GCP audit services, Clinical development and testing, clinical CRO, …
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- Clinical data service / data management
- Clinical monitoring
- Clinical studies monitoring
- Clinical trial services
- Drug safety
- Electronic data management
- Patient recruitement services
- Pharmacovigilance services
- Project management
- Quality / regulatory services
- Quality control
- Quality management
- Regulatory services
- Report writing
- Statistical service / biostatistics / biometrics
- Validation services
- Writing medical
Using our proven Trusted Process and therapeutic expertise, we are a leading contract research organization in clinical trial outsourcing services and consulting for Phase I - Phase IV studies.
Our concentrated experience in these areas enables us to provide an unsurpassed level of investigative site support and unmatched deliverables to clinical trial sponsors.
With a focus on Phase I - Phase IV trials, INC Research is a leading contract research organization that offers unparalleled therapeutic foresight and expertise to support the drug development process. Our full service CRO capabilities and proven Trusted Process makes us an ideal partner for drug developers looking for dependable outcomes and actionable results from a contract research organization.
Our customers receive frequent and clear communication, a mutual understanding of timelines and costs, critical thinking, seamless services, transparent processes, and fast, flawless execution resulting in quality deliverables. All are necessary, in real time, for informed decision-making. INC Research Data Services include:
- Project management
- CRF/eCRF design
- Database design & build
- Data entry & validation
- DCF/query management
- External clinical trial data management (labs, device data, images)
- AE/Con Med/disease coding
- SAE reconciliation
- Online quality & metric reporting
- Statistical analysis plans & reports (Biostatistics)
- Validation programming
- DSMB production & management
- Integrated safety/efficacy summaries (ISS & ISE)
- Preparation of statistical components to NDA
- Medical writing - final study report
Exceptional data management is the heart of the ProgramAccelerate® portion of our Trusted Process. Using the power of the latest technologies and the expertise honed from years of clinical data experience, the database is ready, accurately populated, and locked in an expeditious manner—with verification and validation procedures that ensure quality control every step of the way. This processing is done in synchronization with the clinical team, utilizing the information provided from the trial to ensure efficient processes are employed, regardless of capture method, from the first patient in through to database lock. INC Research is experienced in delivering data studies in EDC, paper and fax modalities globally.
Electronic Data Capture EDC
INC Research has the ability to work with a variety of Electronic Data Capture (EDC) tools and make them work effectively to provide customers the solution that best suits their project needs. We utilize three leading EDC platforms - Medidata Rave, Oracle Clinical On-Site and Phase Forward’s Inform products. Our ability to design, build and deliver high quality databases in all three platforms enables our team to deliver the right EDC solution for every trial.
To compete in today's changing global drug and device development environment, companies must collect and distribute data faster than ever before. INC Research helps its customers harness the power of EDC. Our foundational EDC functionality is based on the leading technology platforms to provide our customers with a broad spectrum of EDC options that suit their needs. We have the ability to manage EDC studies to help our customers take advantage of the efficiencies available through this technology - improved access to data, less paper, reduced cycle time, increased productivity and improved relationships with customers, vendors and other partners.
The biostatistics team at INC Research has a depth of experience with the FDA and the EMEA, which means our teams provide customers with solid guidance on building a statistical plan that will meet regulatory and safety requirements. We provide support for independent Drug Safety Monitoring Boards (DSMB) and a full range of related services. Our biostatisticians are heavily involved in the PlanActivation® stage of our Trusted Process, so protocol and project development are grounded in sound, advanced statistical methodology. As part of a project team, our biostatisticians can provide a critical eye for any data or data handling issues that need to be resolved for analysis. Our experts can lend key data oversight throughout a trial.
INC Research has the ability to develop a variety of functions in its proprietary IVRS/IWRS system and make them work effectively to provide customers with the solution that best suits their project needs. With our study specific development approach, our focus is on having an experienced IVRS/IWRS team in place, helping to provide the IVRS/IWRS solution that makes sense for our customers, and providing effective Randomization and Drug Tracking. Our IVRS/IWRS development, functionality and support provide our customers with a broad range of options that can be tailored to their specific studies. We have the ability to manage IVRS/IWRS studies to help our customers take advantage of the efficiencies available through this technology.
The FSP model targets the separation of core/non-core capabilities within the sponsored organization. INC Research's FSP services include:
- Data Management
- Medical Writing
- Regulatory Document (eTMF) Processing
- Site Contract Management
- Site Payment Administration
Our ability to work within a sponsor's processes and systems or to deliver new processes to the sponsor allows us to act as the sole subject matter expert for a particular function. INC Research uses this functional expertise to become a subject matter expert for a particular function. INC Research uses this functional expertise to drive a continuous process improvement approach into the sponsor's current operations.
The end result of implementing a FSP approach is greater predictability and more consistent delivery of services across all protocols. INC Research currently operates global FSP hubs in Asia, Europe, North America, and South America and can become your functional expert while your in-house teams focus on the science and strategy of executing a successful clinical trial.
Strategy and Regulatory
Key areas of support include:
- Strategic drug development
- Clinical development plans (CDPs)
- Registration strategies
- Optimized exit strategies
- Translational clarity
- GxP compliance strategies
- Due diligence
By leveraging the worldwide capabilities of INC Research, the Strategic Consulting Group provides expertise that blends a global perspective with an understanding of important regional nuances.
Our consultancy is comprised of senior executives from regulatory affairs, clinical research, biostatistics and data management – individuals with expertise gained through hands-on experience as former CEOs and executives from pharma, biotech (both well established and emerging companies), the CRO industry and regulatory agencies. We complement our internal expertise with external thought leader alliances to ensure complete coverage for the entire lifecycle of the product.
Once we have matched our consultancy teams with our customer’s unique challenges, we can provide follow-through by interfacing with INC Research’s global operations. This combination of strategy with tactical execution based on our Trusted Process methodology ensures a comprehensive solution for our customers. Our Strategic Consulting Group offers you timeless advice for timely results.
Global Regulatory Services
We offer regulatory expertise across the entire lifecycle of small molecules, proteins (innovators and biosimilars) and devices. Whether providing operational support or strategic consultancy, our goal is to maximize clients’ potential for success. We understand the importance of time and the value of flawless execution. Regulatory Affairs at INC Research has a global footprint. Staff are located at multiple offices in the US, EU, and Canada. In addition, subject matter experts are located in our offices throughout the world to ensure we maintain a global regulatory umbrella for our clients (e.g., EU countries, Eastern Europe, Asia, India). Although globally distributed, the regulatory groups form one integrated global unit with central oversight from the corporate headquarters in Raleigh, North Carolina. Individuals within the group have substantial hands-on regulatory knowledge gained through successful and diversified experience in large pharma, emerging biotech, CROs, at the FDA and in regulatory forums worldwide.
- Worldwide Regulatory Submissions (NDA, BLA, MAA, CTD)
- Regulatory Strategy and Agency Meetings
- Early Development Consultancy
- DSMBs and DRCs Management
- Chemistry Manufacturing and Controls
- Contemporary Regulatory Interpretation
Clinical trial services
Our drug safety teams are strategically located in different time zones across the United States, Europe and Asia/Pacific to ensure uninterrupted service. We provide global drug safety expertise in all phases of clinical research for Serious Adverse Event/Adverse Event (SAE/AE) collection, evaluation, classification, reporting, and reconciliation. We use either our own or our customer’s drug safety database for timely reporting to regulatory authorities, including electronic European reporting. In addition, to meet stringent timelines for regulatory compliance and SAE follow-up, we provide a 24/7 drug safety hotline.
Our in-house physicians provide round-the-clock medical monitoring services, as well as scientific and medical support for project management teams and investigative sites. Our team consists of seasoned clinicians and clinical researchers who combine many years of patient-care experience with their trial-management expertise. They have a diversity of backgrounds and specialties and cover the range from small proof-of-concept studies to large multinational pivotal studies with equal flexibility. Our highly experienced team enables seamless coverage for studies.
We are committed to ensuring the success of your trial. Our Patient Recruitment Services Group can serve as an integral part of your trial team and identify and manage the most appropriate vendors for your needs. We can develop the best patient recruitment and retention strategies to help you meet key milestones for your program and serve as a liaison to a number of media outlets and other INC Research validated vendors.
We maintain a project centric focus across the organization in support of high performance teams with our Trusted Process. From PlanActivation® to our QualityFinish®, our exceptional teams lead our QuickStart® implementation process for each study, to ensure we aggressively and proactively plan for and execute on critical milestones within agreed upon timelines. Our project teams include key managers from all appropriate functional areas within the organization, each with related therapeutic expertise and firsthand industry experience.
The project lead ensures our customers are provided a notably high quality of service throughout the life of their study. Solid project management skills – ongoing communication with external and internal project teams, proactive management techniques, and therapeutic expertise that secures study success – are the cornerstone of our Trusted Process approach. These skills are provided by project management teams who clearly understand the factors critical to clinical trials.
Quality control steps are built into all of our processes. We have an independent quality assurance department that engages ongoing quality and compliance assessments of all of the services we offer. In particular, we regularly conduct internal process audits to ensure compliance with good clinical practices, standard operating procedures, vendor qualifications, and commitments to clients – all for the purpose of continuously insuring the quality of our services remains at the highest level.
Regulatory Report and Writing
We offer regulatory and medical writing expertise across the entire product lifecycle. Whether providing operational support or strategic consultancy, our goal is to maximize clients’ potential for success. We understand the importance of time and the value of flawless execution. Our Regulatory Affairs and Medical Writing team has a global footprint with subject matter experts located in our offices throughout the world to ensure we maintain a global regulatory umbrella for our clients (e.g., EU countries, Eastern Europe, Australia, India, Mexico). Our team has substantial hands-on regulatory and medical writing knowledge gained through successful and diversified experience in large pharma, emerging biotech, CROs, and FDA.
Our CRAs bring strong monitoring and clinical experience to our customers with most of their experience in our key therapeutic and specialty areas. In addition, each member is fully trained in FDA regulations, ICH guidelines, and GCP/SOP compliance. As a result, our regionally based monitors worldwide thoroughly understand the many complexities associated with trials in the therapeutic area in which they primarily practice, in the region within which they work and accordingly, provide quality and performance feedback, study training and technical support, data query resolution, source document review, and site management for all types of visits.
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