Our biometrics teams consist solely of experts in data operations, biostatistics, medical writing, safety and pharmacovigilance, and project management of these services. Working as a seamless unit, they can provide you with complete biometrics services, or work as stand-alone functions to supplement your existing capabilities.
We make databases easy
We manage all your clinical study database needs using processes we’ve built for speed and efficiency. We internally monitor data quality and study performance in real time, providing meaningful feedback to all teams. And we make sure you’re kept in the loop with frequent, clear communication.
Combining the latest technologies with years of clinical data experience, it’s our target to get your databases ready, accurately populated, and locked as quickly as possible. To do that, we’ve set up a whole suite of verification and validation procedures that ensure real time quality control. And we work closely with clinical operations teams, helping to make sure everyone is working in the best way, regardless of the chosen data capture method.
We’re set up for electronic data capture
There are a few industry-leading EDC platforms that we use most frequently. If appropriate, we’ll recommend them for your studies because they improve access to data, using less paper, cutting cycle times, increasing productivity and improving relationships with vendors and other partners. The platforms we work with are well built and adaptable for almost any type of study. We have a lot of experience designing, building and delivering high quality databases in all of them. We’re also happy to work with other existing EDC platform suppliers that you may have.
We don’t just collect data, we make sure it’s meaningful.
There’s a massive amount of data generated by clinical programs, and the way it’s collected and handled can vary between studies. We’re here to help you effectively collect and process information quickly and cost efficiently without overstretching your own resources.
By looking across your entire clinical development program, we can standardize processes not just in one trial but across many, saving you both time and money. And because our biostatisticians are trained to provide the highest-quality statistical output and to anticipate and overcome potential challenges, we can ensure you obtain accurate results that support rapid decisions.
Take a look at the kind of things we do:
- Comprehensive statistical analysis plans
- NDAs and MAAs
- Data review and data summarization
- Data Monitoring Committee and/or blinded data review meetings
- Adaptive Designs, including stoppage rules and sample size re-estimation
- CDISC SDTM, ADaM and CDASH data collection
- Outcomes research and health economics
- Patient registries
- Epidemiology research
- Submission support, meta-analyses and integrated summaries of safety/efficacy (ISS/ISEs) for Common Technical Documents (CTDs)
- Stand-alone statistical reports and/or statistical input and review of clinical study reports
- Electronic CRF tabulations according to regulatory guidance
Meeting regulatory requirements in biostatistics
We’ve worked extensively with both the FDA and the EMEA from a biostastistics standpoint, and we’ll provide you with 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.
A little bit more about CDISC
As soon as CDISC standards were created, we adopted them, and have since earned the status of Platinum Member. Our SDTM experts have on average five years’ SDTM experience. Collectively, we’ve mapped more than 700 studies to SDTM standards, 800 to ADaM standards and 250 with define.xml to both, all validated using OpenCDISC Validator.
Let us take care of the details
Developing a drug – from conception to market – involves writing scientific documents in a highly regulated environment. Our global medical writing team delivers clear, concise, scientific and accurate documents that are fully compliant with the International Conference on Harmonisation (ICH) and regulatory authority requirements. Your decision to transfer writing obligations to our medical writing department will create additional time in your schedule for other product development activities.
Our writers understand your projects
We believe that strong scientific knowledge is essential in order to provide you with the best possible writing support for your projects. Our medical writers are familiar with a wide range of therapeutic areas, and many of them have post-graduate degrees. Writers approach their assignments in a team-based environment that includes biostatisticians, pharmacokineticists, physicians, clinical project management experts and regulatory specialists. In addition, we have team members that specialize in editing and electronic publishing, to be sure that document accuracy and submission-ready publication requirements are met.
Quality doesn’t have to cost time
Our team of medical writers will review your clinical development program to establish timelines, best practices and develop a mutually agreed-upon medical writing plan for each document. All of our documents undergo a rigorous process that includes reviews by a quality reviewer, biostatistician, senior medical writer, and medical liaison. The reviewers provide feedback on clarity, grammar, readability, completeness, conciseness, internal logic, and adherence to style guides, template requirements, and your pre-established preferences. This process ensures that high quality documents are delivered to you each and every time, thus reserving your time for other product development activities.
No job is too big or too small
Regardless of the scope and size of your project, our medical writing team is here to assist you. We have the bandwidth and experience to assign a medical writer to either an individual document or to a team that focuses on global medical writing activities. Our writers can develop and customize documents to meet your style guides and templates or we can follow our established standard operating procedures. In addition, we can work within the framework of your document management system, or manage the entire process. We also offer editing and quality control services for documents created by third parties.
Further detail on the types of documents we create:
- Preclinical and scientific reports
- Study protocols (Phase I to IV)
- Investigator brochures and Investigational Medicinal Product Dossiers (IMPD)
- Informed consent forms
- Patient narratives
- Aggregate reports (PSURs, PADERs, DSURs, PBRERs)
- RMPs and REMS
- ISSs and ISEs
- Regulatory submissions
- IND summary sections and annual reports
- CTD, NDA and MAA technical/clinical summaries
- Reports for ClinicalTrials.gov
- Publication plans
- Abstracts, posters and manuscripts
- Medical slide sets
- Reimbursement/value dossiers
See how we have helped a customer reduce delivery times for their CSRs
A large pharmaceutical company asked us to collaborate with two other suppliers to design processes, best practices, risk management strategies and metrics for the development of clinical reports across their entire portfolio. The immediate objective of the project was to significantly reduce median delivery times from database lock to final CSR.
To meet the requirements of this demanding project, we formed a highly coordinated team across multiple locations in the United States and Europe.
During the initial phase, the median time of delivery from database lock to final CSR decreased from 120 days to 55 days (the target was 57 days), with an overall cost saving of 55%. We also exceeded our customer’s quality target, with an overall error rate of < 5% with no critical errors.
Biometrics project management
We specialize in the intricacies of data
As the main point of contact for your biometrics functions, our Biometrics Project Managers (BPMs) provide the essential skill required to streamline communication and ensure consistency across all aspects of data processing, analyzing and reporting in large clinical development programs.
At the helm of our biometrics offering, we ensure a smooth and timely execution of all data-related services, providing you with quality documents, on time and within budget.
Biometrics project management is a vital function, unique to INC.
All of our biometrics project managers have over a decade of experience managing biometrics functions and have worked together over the years to establish key indicators to measure project status and metrics.
For every assigned lead BPM, we have a back-up BPM assigned at our cost to ensure non-stop coverage of study activities. We focus on the management of study activities so experts in other functional areas can dedicate their time to what they do best – delivering a quality product on time and within budget. We assess study risks, plan for contingencies, and escalate as necessary to executive leadership.
The responsibilities of a biometrics project manager
Serving as the main point of contact for our wider biometrics teams, our specialized project managers are responsible for:
- Assigning teams and managing timelines
- Representing biometrics functions at key customer meetings
- Scheduling and leading internal project calls and providing meeting minutes
- Scheduling and managing customer calls and providing meeting minutes
- Managing vendor relationships related to data (such as central labs and pharmacokinetics functions)
- Managing finances/budgets
- Working closely with clinical project management teams
What makes this specialized role so important?
- Experience: Each BPM is an expert, trained in biometrics, providing a single, consolidated point of contact for all vendors, all clinical teams, and all customer teams.
- Consistency: BPMs closely monitor processes and decisions made across studies to ensure consistency and that all team members are informed appropriately.
- Frees up time: BPMs are representatives for our functional areas allowing our teams to focus on the core work.
- Develops relationships: BPMs build teams in conjunction with the functional department leads based on the needs of the customer.
- Shares responsibility with Clinical: from study start up, the clinical project manager focuses on the clinical aspects and the BPM focuses on the Biometrics aspects in parallel.
See how our BPMs can get biometrics teams back on track
A program of multiple studies in a difficult therapeutic area with overlapping timelines was becoming difficult to manage across the customer’s biometrics teams, and resourcing and budgeting were stressful for the teams to manage in addition to their core functional responsibilities. The program had strong individual leads but inconsistent project management.
We added Biometrics project managers to the program immediately. Assessments and corrective actions were made in processes, resources, and budgeting, and communication plans were put in place and followed across the program.
Within a few months, the customer could see drastic improvement, timelines were being met and teams were delivering quality work. In less than nine months, INC Research was awarded new studies by the customer.
Learn how we’ve helped to improve communication and quality of deliverables
A program that required complicated SDTM and ADaM deliverables for two Phase III pivotal studies were in jeopardy. Detailed timelines were not developed and communication was stressed under the tight timelines.
A BPM was added to the program immediately. Detailed timelines were developed, roles and responsibilities were defined, communication plans were set up with the customer directly, and clear deliverables were committed to.
All deliverables were met and the customer met their corporate goals.
Safety and Pharmacovigilance
We take safety seriously
With safety concerns becoming increasingly common among doctors and patients, having robust and accurate data will also help you gain their trust in your product.
Whatever your needs, we know how to help you
Our safety and pharmacovigilance service has been one of our core offerings since 1992. We have a global team of experts who can support you across all phases of clinical trials and post-marketing surveillance, ensuring timely collection, analysis and reporting of your safety data according to each country’s regulations. Our experience covers virtually all therapeutic areas.
We adapt to your existing processes
We were the first CRO to use Oracle’s fully validated Argus Safety as our in-house data collection system. However, we are comfortable working with any database system you may use, including ARISg, AERS, ClinTrace and even bespoke ones. With effective data migration processes in place, we are able to design safety strategies for your projects that will work seamlessly alongside your existing processes and resources.
We offer flexible partnerships
When monitoring safety, data processing and management needs can fluctuate widely over time, especially if adverse events are unexpected. Our flexible FSP partnerships are designed to ensure that we support you with adequate resources at all times, while avoiding unnecessary costs. We will quickly increase resources during periods of high demand, which is essential to ensure regulatory compliance, especially when handling SUSARs, SAEs and AESIs. In addition, when appropriate, we can transfer high-volume workloads that are repetitive in nature to more cost-efficient locations, generating savings without compromising on quality.
See how we have helped a customer monitor SAEs in a large trial
A major pharmaceutical company needed a partner to track SAEs in a Phase IIIB trial including more than 9,000 patients with obesity-related cardiovascular risk across 308 sites in Europe, Latin America and Australia.
Thanks to our global scale and experience, we were able to put in place a robust strategy that used comprehensive tracking tools, allowing us to process more than 11,000 SAEs and outcome events in seven years.
The process was a success, achieving a great result for our customer.