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Discover KerusCloud, the essential simulation and tool optimizing clinical study design and analysis strategies for success.

KerusCloud is a next generation simulation software that delivers rapid, -driven insights for more quantitative and collaborative decision-making. Its use de-risks clinical projects by fully optimizing them for success. This uniquely powerful platform supports earlier engagement by in the clinical development process, helping them to share key insights across all stakeholders to drive strategy through evidence-based design and analysis.

KerusCloud Revolutionize study design with advanced statistical modelling and simulation

Traditional Study Design Support

Treatment Effects

Sample Size Calculations High Risk Protocol

Primary Endpoint

Decision Criteria

Patient Level Data (CT) Endpoints

Data Patient Level Data (RW) Derivations Initial Simulations

Objectives Literature Review Design Options Scenario Evaluations

Initial Scoping Digital Landcape Mapping Assumptions and Options KerusCloud Simulations De-Risked Protocol and CDP

Strategy Domain Experts Decision Criteria Review and Update

Constraints Inter-relations Analysis Options Final Simulation

Summary Statistics Study Populations

Kerus Library Treatment Effects

KerusCloud Approach to Study Design

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6 STEP 7

The Clinical Trial Target Study Protocol Draft Final Design Process Product Development Question Concept Synopsis Protocol Protocol Profile Plan

Designed by statisticians with in-depth experience in clinical in real studies. With KerusCloud, study design and analysis development, KerusCloud transforms study design and strategies can be fully optimised prospectively in just a few planning by going beyond simplistic traditional statistics hours to ensure that real studies can achieve statistically approaches which often fail to account for the trade-offs and clinically meaningful outcomes. between design features and the sources of uncertainty

Exploristics Ltd. find out more 24 Linenhall Street Belfast, T +44 (0) 28 9600 1996 Northern Ireland BT2 8BG [email protected] 3 exploristics.com/keruscloud-platform-overview

Leveraging the Power of Statistics

KerusCloud Probability of Probability of Precision Making an Impact 3x Development Success 41 % Medicine Study Success

Increase the probability of success Increase the probability of success by over three-fold for a development programme. 41% for a precision medicine study.

KerusCloud supports a multi-dimensional optimization process where pinpointing the right combination of design Years Removed from USD Saved on features can dramatically -4 the Development Time + 20m a Single Study increase study success. Without adding cost, KerusCloud has already Decrease development time by 4 years Save $20M on a single study. helped organisations to: for a clinical study.

Augmenting statistical expertise Enabling earlier statistical input KerusCloud supports statisticians in influencing study KerusCloud enables statisticians to collaborate design at every phase of clinical development, ensuring much earlier in the planning of individual studies or that projects are de-risked and driven by evidence- of development programmes. This is supported by based decision-making from inception to completion. a key strength of the software, the ability to construct By using KerusCloud, statisticians can expand on their scenarios where there are multiple sources of own expertise with further unique, data-driven, insights uncertainty that are likely to impact the outcome. into the and analysis strategy so that With KerusCloud, statisticians can evaluate and the best approach is selected to give development implement strategies that minimise the risks programmes the greatest chance of success. from the outset.

Diverse and complex data-handling Sharing key insights on design A highly versatile platform, KerusCloud can handle not Data from a variety of sources can be incorporated into only the diverse and complex data collected routinely in KerusCloud where they are used to create synthetic clinical research but also new data types from emerging datasets or virtual patient populations which inform the digital technologies, facilitating their integration into clinical generation of highly realistic study scenarios for evaluation development and precision medicine approaches. Its in parallel, in silico, in minutes. Capturing this complex use supports statisticians in ensuring that clinical project multi-dimensional information both quantitatively teams can harness the growing variety of data sources and visually in a heatmap, KerusCloud can be used by now available to better understand the complicated statisticians to share key insights across project teams inter-relationships between risk factors, outcomes on the study design features that drive success. and treatment effects when designing a study.

Exploristics Ltd. find out more 24 Linenhall Street Belfast, T +44 (0) 28 9600 1996 Northern Ireland BT2 8BG [email protected] 4 exploristics.com/keruscloud-platform-overview

KerusCloud Interactive Heatmap Analysis KerusCloud Virtual Population Contruction

KerusCloud an exceptional tool years of research and development on copulas for generating complex multivariate data that ensure the As a SaaS platform with no need for installation properties of the marginal distributions as well as the or maintenance, KerusCloud provides correlation structure is maintained. Consequently, statisticians with a uniquely powerful and easy KerusCloud can generate complex data comprising: to use in silico tool with which they can: Common features such as subgroups and strata, Rapidly construct complex simulations to generate risk factors/covariates, multiple outcomes results that support project timescale. Special features including derived variables, Influence more decisions on important study factors: , truncation and right study population characteristics, sample size, schedule, study power, stratification, Using this highly realistic virtual data and its intensive multiple endpoints and observation time, analysis processing power, KerusCloud can run thousands of Monte strategy and decision criteria. Carlo simulations in minutes to evaluate the probability of success of many, varied study designs and analysis options Overcome challenges with implementing new to achieve study or programme objectives. These utilise methodologies and generating simulation code. the comprehensive library of design, analysis and decision tools available with the platform. Flexible and user-friendly, Communicate complex statistical information across KerusCloud also offers the option of exporting patient level stakeholders to help direct design and analysis data or the results into other packages for further analysis. strategies. KerusCloud a new release KerusCloud a unique approach Building on its core capabilities, the KerusCloud KerusCloud offers a unique approach, generating Spring 2021 release now offers a of virtual patient populations that are the most realistic new innovative features including: representation of data collected in modern trials. It can model variables based on any data type and An expanded analysis library of statistical tests statistical distribution, as well as the correlation including , and between variables. This innovation is the result of additional tests for proportions and derived variables

Exploristics Ltd. find out more 24 Linenhall Street Belfast, T +44 (0) 28 9600 1996 Northern Ireland BT2 8BG [email protected] 5 exploristics.com/keruscloud-platform-overview

NEW KerusCloud Advanced Analysis Library NEW KerusCloud Metadata Repository?

so that the performance of all commonly applied construction of complex study scenarios in real time whilst analysis strategies can be assessed to identify the data is kept safe with best-in-class security features optimal approach, control for sources of bias and including multi-factor authentication, data encryption and evaluate alternative designs, such as the application disaster recovery to give you complete peace of mind. of historical controls. for maximising value Enhanced for even more realistic KerusCloud study simulations, including time-to-event data with KerusCloud can be used in a wide range of applications flexible censoring distributions, so virtual population and is particularly useful for maximising the evidence datasets more closely represent actual data generated at important transition points during clinical generated in real-world studies. development, such as proof of concept or commit to late stage development. It adds significant value as standalone A meta data repository to keep track of integrated tool or as a precursor to existing design tools as it can data sources so that assumptions are linked to the efficiently narrow the potential options available. original data sources for greater transparency and ease of auditing and review. KerusCloud for maximising impact A new administration portal for tighter control over KerusCloud maximises the impact of statisticians platform usage and costs with managed user access offering a unique rapid quantitative tool with which to and more flexible allocation of KerusCredits so that assess, visualise and communicate the best approaches you only pay for what you use. across project teams early on in protocol development. Robust collaboration and sharing tools ideal for With consistently high attrition rates in clinical trials, the distributed teams providing everyone access to the role of the has never been more important same virtual population data and simulation project. for informed drug development strategies. So, discover and share a more data-driven approach to clinical Enhanced scalability, robustness and security study optimisation. Add KerusCloud to your design delivering enterprise grade protection for rapid toolbox today and transform clinical trial success.

Exploristics Ltd. find out more 24 Linenhall Street Belfast, T +44 (0) 28 9600 1996 Northern Ireland BT2 8BG [email protected] 6