Clinical Risk-Based Monitoring (RBM) Solutions

In addition to the traditional one-size-fits-all study monitoring, Recursis RBM solutions go a step further to help organizations focus on identifying and managing risks unique to each study and protocol.

Improved Study Timelines: Early issue detection and efficient problem resolution ensure smoother study conduct, preventing delays caused by major protocol deviations or data discrepancies.
Regulatory Compliance: RBM aligns with regulatory expectations, promoting compliance and ensuring the study meets standards for approval and acceptance.
Efficient Resource Allocation: RBM focuses monitoring on high-risk areas, optimizing resource allocation, saving time, and reducing unnecessary costs.
Increased Patient Safety: Timely risk identification allows for a proactive approach to managing safety concerns, reducing adverse events and ensuring participant well-being.
Early Issue Detection: RBM, using KRIs and continuous monitoring, facilitates early issue identification, allowing prompt intervention and reducing serious problems later in the trial.
Enhanced Data Quality: RBM emphasizes data integrity through continuous monitoring and adaptive strategies, enhancing the credibility of study results.
Adaptability to Study Complexity: RBM offers a flexible monitoring approach that adapts to study-specific needs, accounting for varying complexities.

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Execute Oncology Data Analytics and Automate at Scale

Consolidate tumor scan assessment data from investigators and central review for comparative analyses.
Automate response evaluation criteria in solid tumors (RECIST and iRECIST) analytics as data arrives every day for chemotherapeutic and immunotherapeutic modalities.
Validate oncology statistical analysis plans and automate visualization in GxP environments.
Generate, analyze, and set alerts on PFS, OS, ORR, DCR, and calculated endpoints metrics daily.
Automate data cleaning processes important for downstream analyses including prior regimens, mutations, target and non-target lesion locations.
Create visual and email alerts for protocol deviations, scan entry delays, and overall response mismatches.
Enrich data with genomics, biomarker and other stratification factors for more powerful analysis.

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Make medical monitoring and project data reviews efficient and effective.

Patient profiles for complete view of key study information, from screening to follow-up.
Monitor safety signals based on labs, adverse events, ECGs, vital signs, physical exams, and ePRO data.
Analyze dosing and exposure data as it relates to study endpoints and efficacy.
Quantify and share key study outcomes in near real-time, as they emerge.
Access fresh data and visuals for effective communications with sites and sponsors.

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Analyze and visualize all your clinical study data with precision.

Analyze inclusion and exclusion reasons.
Track screening and enrollment progress.
Understand safety events leading to discontinuations and interruptions.
Visualize efficacy data as it becomes available.
Use PK and PD for exploratory and confirmatory analyses.
Segment responder populations by biomarker data.
Get CTCAE and DAIDS graded safety labs you need for medical monitoring.
Have patient reported outcomes (ePRO) data integrated for analysis.
Integrate medical histories and real world data into your clinical visualizations.
Integrate analytics with mainstream EDC systems:
- VEEVA Vault™ CDMS
- Medidata RAVE™ EDC
- Viedoc Clinic™
- Clincase™
- Oracle Clinical™
- Argus™
- Medrio™
Add auxiliary sources into your analyses easily.
Provide sample management with quick reconciliation and data cleaning reports.
Augment data management team capabilities with clean patient tracking analytics.

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Put your pre-clinical research data under a microscope.

Visualize integrated animal study PK, ADME and Tox data.
Accelerate generation of key tables, listings, and figures for project reviews, presentations, posters, IND, and CTA regulatory submissions.
Expand understanding of chemistry lead generation and optimization data.
Make use of genomics and metabolic pathway data.
Find new leads in high throughput biology and screening data.
QC and analyze integrated assay results and biological sample databases.
Fit and analyze IC50 data
Add and integrate LIMS data.
Link to ELN data.

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What you get

Secure Data Transfers

You get secure file transfer, data storage, and deep GxP know-how to support data transfer agreements between organizations and CROs in validated environments.

Technical Expertise

Certified expertise in TIBCO Spotfire® and experience with several other data visualization platforms including Tableau® and Microsoft Power BI®. We deliver projects with impact, agility, and provide fast results to end users that they can see and use.

Scientific Visualization Templates

Automated data visualization templates customized for disease areas including cardiovascular, oncology, immunology, hepatology, and more. Study specific calculations to help you monitor outcomes, check the accuracy and completeness of your data quickly. Study dashboards templates customized for your experimental design, key end points, and KxIs. We do this so your scientists can focus on science.

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How we work with your teams

Advisory Services

Customized consulting engagements to help you assess your organization’s readiness for analytics.

We help you avoid spending money on expensive software your organization isn’t ready to use.

We work directly with end users and data to give you real advice, useful recommendations, and working prototypes for project team members to use.

Project Services

We engage when you are ready.

Profit from decades of hands-on project experience and certified expertise in data visualization, pipelining, SQL, data warehousing, EDC analytics, and commercial cloud data platforms because data visualization and data science doesn’t need to be complicated.

We deliver projects with impact, agility, and fast results end users can see.

Managed Services

Add a strategic partner that knows how to scale and support solutions inside global organizations.

We support back-office data operations, user training and education programs, visualization platform administration, migrations to the cloud, and ad interim strategic data management and informatics leadership for your organization.

Whether you are a small company or a large, Recursis is an experienced support partner and guide for your business analytics strategy and software needs.

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