PRECISION MEDICINE



Clinical Pharmacology

Our pharmacology experts provide answers to important questions related to the pharmacodynamic and pharmacokinetic properties of small and large molecules.

  • Dose simulation, selection and optimization
  • Selection of biomarkers and endpoints
  • Optimization of trial design
  • Population pharmacokinetic and pharmacodynamic modeling
  • Exposure-response modeling

Translational Medicine

Our collaborative work with leading international IBD specialists and their research teams at major clinical sites, provides our clients with access to a network of clinical translational science expertise and services through a single point of contact. Multi-center standardized approach to deliver quantitative and validated state-of-the-art data

  • Immunohistochemistry
  • Flow cytometry
  • Transcriptomics
  • Proteomics
  • Microbiome
  • Metabolomics

 

CLINICAL DEVELOPMENT



Trial Design

Expertise in GI clinical trial design, ranging from proof of concept trials to large scale phase 4 studies.

Medical Writing Services

Communication is key. Robarts Clinical Trials has a diverse team of medical, scientific, bio-statistical, epidemiology, regulatory, technical and scientific writing experts. Medical writing and study design services can be integrated as part of full services, or on a stand-alone basis. We are GI experts with a niche specialty in Inflammatory Bowel Disease.  Our medical writers have a diverse range of skill sets that allow them to take on a range of therapeutic and content-specific projects, including regulatory and technical writing. We can partner with you to develop protocols, Clinical Study Reports, Investigator Brochures, safety reports, Informed Consent Forms, meeting abstracts and posters, manuscripts, study charters /manuals and literature reviews.

Project Management

We take on as much as you need. We offer a complete range of services that can be customized to meet your specific project management needs.

  • Secure, globally accessible study web portals and clinical trials management system (CTMS) tools
  • Site/investigator recruitment and selection
  • Site start-up
  • Site management and clinical monitoring
  • Vendor and sub-contractor relationship management
  • Meeting, workshop and event planning and execution

Document Management

  • Delivers a complete and inspection-ready Trial Master File
  • Coordinates and controls flow of electronic and paper documents
  • Secure storage and retrieval systems ensure accessibility to authorized personnel
  • Documentation is reviewed throughout the lifecycle of the study
  • Gas fire suppression in conjunction with secure storage
  • All-encompassing services from TMF setup to archiving

Data Management

We are data-driven. Robarts Clinical Trials’ innovative approach to clinical data management is shaped by superior therapeutic expertise in the inflammatory bowel diseases and industry experience. We precisely pair technology and proven processes with clinical studies to streamline the route to more efficient and effective data collection and management. Our study-specific approach begins with a thorough review of specifications, client preferences/history and data planned for collection, paired with tailored recommendations that best serve the needs of study sites and project teams. Our processes to capture, maintain, clean and deliver data are robust, efficient and scalable. We offer a full suite of services utilizing electronic and/or traditional paper data capture methods including:

  • Case Report Form (CRF)/eCRF design (including a suite of standard IBD-specific eCRFs)
  • Database design and implementation
  • Data validation, review, and cleaning
  • Medical coding
  • Comprehensive management of data from third-party electronic data vendors

Biostatistics and Statistical Programming

We are significantly analytical. Robarts Clinical Trials has a unique set of capabilities in biostatistics and statistical programming for IBD clinical trials. Our expert biostatisticians have a long history of collaboration with clinical researchers, and a broad knowledge-base in all aspects of clinical trials, from the initial design and calculation of sample size requirements, to analysis, display and interpretation of data. We leverage our vast statistical experience to design studies in a way that speeds submissions. We plan the analyses you will need before the study begins and provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses. Our thorough validation and quality control processes eliminate the need for corrections and ensure accurate results. Robarts is a CDISC Gold Member with CDISC “Trailblazer” status due to our continued involvement and contributions to new IBD-specific standards. Our unique experience in consulting and operationalizing CDISC/SDTM /ADaM standards for our clients includes data consolidation, migration, and conversion. Our expertise includes:

  • Protocol development, including sample size and power calculations
  • Randomization schedules
  • Statistical analysis plans
  • Statistical programming and validation in SAS®
  • 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
  • NDA-ready data listings
  • CDISC-compliant datasets
  • Thought leadership and operational experience with CDISC standards (SDTM and ADaM)
  • Integrated safety and efficacy summaries
  • Adaptive design consulting and simulation support
  • Translational research support
  • Data monitoring board management and support

Monitoring

Experience matters. Robarts Clinical Trials has a scalable and hybrid international network of Clinical Research Associates (CRAs) who work extensively in IBD and bring this unique knowledge to site management and monitoring. Robarts uses an adaptable network of over 60 contract and staff CRAs across 30 countries in North America and Europe, with an average of over 5 years of clinical research experience. Our CRAs receive extensive quality, and IBD-specific training; the latter of which includes current best-evidence for diagnostics, treatment, outcomes and methods for assessment of disease activity. In collaboration with their project teams, our CRAs ensure that complex protocols are implemented in conformance and compliance across all sites, and provide specific project and allied skills training to sites across the clinical trial continuum.

Regulatory

We can effectively navigate complex and evolving environments. Robarts Clinical Trials provides global regulatory services; assuring the execution of high quality submissions throughout the lifecycle of clinical trials. We leverage a breadth of regional and therapeutic experience and maintain cross-functional and local collaborations to effectively navigate increasingly complex global regulatory environments.

Drug Safety

We are committed to patient safety. We provide clients with high quality and efficient management of clinical trial safety data. Our drug safety experts collaborate with clients to deliver solutions tailored to individual projects supporting the development of medical products. We provide the following services in accordance with applicable regulations within a defined quality management system:

  • Processing adverse events from clinical trials
  • Preparing DSURs (Development Safety Update Report) and other aggregate reports
  • Performing signal detection and benefit-risk assessments
  • Preparing safety management plans
  • Preparing medical monitoring plans

Quality Assurance

We are passionate about quality! We support clinical studies through oversight of the Robarts Quality System, including:

  • Quality System documentation, such as Standard Operating Procedures (SOPs) and Work Instructions
  • Internal system reviews
  • Site audits
  • Vendor assessments
  • Final study report audits
In addition, Robarts Quality Assurance facilitates Sponsors and their representatives as they assess Robarts as a vendor, assists with Inspection Readiness and hosts inspections from agencies.

MEDICAL IMAGING



Image Management

Central Image Management Solutions (CIMS)

Accurate and reliable assessment of disease activity is critical for precise estimation of treatment effects. Robarts’ proprietary CIMS technology was developed in recognition of the critical need for objective assessment of disease activity in early drug development for IBD, as well as the need for improved clinical trial efficiency. Our collaborative research efforts have shown that enrollment bias and placebo rates are both reduced with central evaluation of endoscopic images. We have expanded our CIMS technology to facilitate expert centralized assessment of both histopathology and magnetic resonance images to address the growing interest in measurement of disease activity beyond endoscopic appearance and the need for noninvasive assessment, a factor that is particularly important for disease states that require serial assessments during the conduct of clinical trials.

Robarts’ Central Readers are gastroenterologists, gastroenterology pathologists and abdominal/gastrointestinal radiologists with therapeutic expertise in inflammatory bowel disease. Our Central Readers are experienced in reading endoscopy images, digitized histological images and MRI images. They are familiar with the outcome scoring for the therapeutic indication being assessed and receive ongoing training according to best practices and clinical research standards. The curricula vitae, record of good clinical practice, and assessments of intra- and inter-reader variability are maintained at Robarts as evidence of ongoing Central Reader qualification. Currently, Robarts has 24 endoscopists, 5 GI pathologists and 3 radiologists participating as qualified Central Readers on our CIMS studies.

Endoscopy

Mucosal healing is a regulatory requirement for contemporary IBD trials. Robarts Clinical Trials’ CIMS technology facilitates video assessment of endoscopic disease activity and is the most widely recognized, integrated hardware/software/service solution for global IBD trials.

Our 21CFR11 compliant technology allows our clients to submit their endoscopy data with confidence. Data are fully auditable, protected, and reliable. Videos and images are captured by, and accessible to credentialed study-affiliated individuals only, on trial-specific kits. These videos and images are securely encrypted and Protected Health Information is made available to authorized users only. Video/image and data files are uneditable.

Histopathology

We recognize that there is more to IBD than meets the eye. Endoscopic appearance and mucosal healing are critical measures of disease activity, but we are also looking beyond the endoscope. Microscopic inflammation is a key driver for disease relapse and a predictor for poor outcomes. Histologic assessment is increasingly specified in IBD clinical trial endpoints, and may eventually prove to be the gold standard for measurement of disease activity. CIMS for histopathology is an integrated biopsy sample and image management software solution. Robarts Clinical Trials partnered with international expert GI pathologists and leading imaging software developers to offer a distinctive and competitive service for centralized histological assessment.

Magnetic Resonance Imaging

A safer, non-invasive method for disease activity assessment has arrived. Although ileocolonoscopy is the reference standard for objective evaluation of mucosal disease activity in Crohn’s disease (CD), the inability of the procedure to assess transmural inflammation or detect extra-luminal complications, and its failure to assess the terminal ileum in a considerable proportion of patients are important limitations. Magnetic resonance enterography (MRE) has high diagnostic accuracy for the detection of CD related complications (i.e. stenosis, fistula and abscesses) and for assessment of luminal disease activity. This procedure does not require exposure to ionizing radiation, and is considerably less invasive than endoscopy, which is important given the regular need for serial assessments in clinical trials. The ability of MRE to assess disease activity beyond the endoscope (transmural or isolated small bowel disease) in clinical trials may lead to inclusion of a broader population of patients, improved patient selection, retention and safety, and increased efficiency to detect a treatment effect. Robarts Clinical Trials has added this low-risk, non-invasive imaging option to our array of client solutions, and we have partnered with international expert radiologists with expertise in IBD for centralized assessment of clinical trial MR images.



SITE ENGAGEMENT & TRAINING

***NEED TEXT HERE (?Barrett/Lisa)

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