Biotech and pharmaceutical companies generate enormous volumes of data, yet many face challenges with fragmentation. Pharmacology, pharmacokinetics (PK), and toxicology data are often isolated in different locations and formats, making comprehensive analysis difficult. This lack of integration hinders scientists from evaluating all relevant data together, slowing the selection of optimal lead compounds and clinical candidates. It also introduces inefficiencies in decision-making and complicates regulatory submissions, increasing the risk of delays.

Resero Analytics solves this problem by integrating the separate data sources into a secure, searchable database on Amazon Web Services (AWS). Whether the data originates from PDF study reports from CROs, or Excel files from internal laboratories, our system extracts, harmonizes, and loads it into a private, cloud-based instance. Once centralized, scientists can access and analyze their data seamlessly with Resero’s TurboToxicology and TurboPKTK software, enabling faster and more informed decision-making, streamlined study reporting, and more efficient regulatory submissions.

At Resero Analytics, we provide both software and services to deliver rigorous, data-driven scientific documents that ensure clear, compliant submissions and minimize the risk of delays for biotech and pharma clients.

Evaluating Compounds with Advanced Analytics

Gaining actionable insights from data is essential for informed decision-making. Resero Analytics empowers scientists with interactive data visualizations, enabling precise compound evaluation. Our tools facilitate seamless comparisons within and across structure-activity relationships (SAR), providing a deeper understanding of exposure-response relationships for both pharmacological and toxicological endpoints.

Key capabilities include:

• Dynamic Data Visualizations –Compare compound properties and identify trends across different drug classes.
• Development Projections – Forecast potential risks, including drug-drug interaction (DDI) liabilities and in vivo toxicology challenges.
• Comprehensive Reports – Summarize compound benefits and risks in PowerPoint and Microsoft Word formats for convenient review and presentation, including regulatory documents.

Resero Analytics also enables benchmarking against FDA-approved compounds by leveraging curated data for nearly 1,000 new molecular entities. This enables scientists to enhance risk assessments by comparing their compounds’ safety profiles with those of successful FDA-approved drugs.

Accelerating Regulatory Submissions

Regulatory submissions demand precise, well-structured documentation to meet global agency standards. Resero Analytics transforms study data into submission-ready nonclinical sections of the Common Technical Document (CTD), ensuring clarity, compliance, and efficiency. Our expertise supports IND, NDA, and BLA filings by generating critical CTD components, including:

• 2.4 Nonclinical Overview – A high-level analysis of pharmacology, pharmacokinetics (PK), and toxicology findings, integrating key conclusions for human risk assessment.
• 2.6 Nonclinical Summaries – Comprehensive written and tabulated summaries covering pharmacology, PK, and toxicology.

With our integrated database and associated software, users can efficiently create high-quality CTD sections while maintaining regulatory compliance, reducing submission risks, and accelerating timelines.

Real-World Applications: FDA and National Toxicology Program Data

Resero Analytics transforms publicly available regulatory data into searchable databases, very similar to what we do for biotech and pharma companies. to help them with drug development. The FDA’s approval summaries contain critical pharmacology, ADME, and toxicology data, yet accessing and analyzing this information efficiently can be challenging. Resero has curated this data for nearly 1,000 FDA-approved drugs, including histopathology findings and exposure assessments, providing a valuable resource for comparative analysis.

Beyond FDA data, Resero has also digitized and structured toxicology data from the National Toxicology Program (NTP), which includes thousands of short-term and long-term animal studies. Much of this information was previously locked in legacy PDFs, making it difficult to search or analyze. Using Natural Language Processing (NLP) and Optical Character Recognition (OCR), Resero has extracted and organized these datasets, enabling scientists to compare their compounds against both FDA-approved drugs and historical toxicology data. This approach enhances risk assessment, supports informed decision-making, and strengthens regulatory submissions.

Who Benefits from These Services?

Biotech companies have the most to gain from Resero Analytics’ software and services, as many lack the infrastructure to efficiently integrate data from multiple studies. Without the right tools, consolidating pharmacology, PK, and toxicology data becomes a major hurdle. Resero’s cloud-based platform eliminates these barriers, allowing companies to seamlessly access, visualize, and analyze their data—without the burden of extensive internal IT resources.

Pharmaceutical companies also face significant challenges in managing data trapped in internal silos. We’ve worked with organizations that have spent years attempting to unify their study data. Resero offers a flexible integration strategy, serving as either a primary data warehouse or an interim solution to bridge the gap while companies transition to in-house capabilities. By providing a streamlined approach to data management, Resero empowers scientists to make faster, more informed decisions.

Transform Data into Actionable Insights

Data fragmentation need not be a barrier to innovation. Resero Analytics equips biotech and pharmaceutical companies with the tools to integrate data seamlessly, analyze results with accuracy, and navigate regulatory submissions with confidence. By breaking down silos and transforming complex datasets into structured, searchable insights, we help accelerate drug development and improve decision-making.

Discover how Resero Analytics can streamline your data management and optimize your development pipeline. Schedule a discussion today and take the next step toward smarter, faster drug development.