Clinical Trial Software Development

Mathematical models and quantitative analysis help life science companies to choose the optimal clinical trial design. Predictive modelling and computer simulation help to calculate the optimal dosing and other pharmacokinetic and pharmacodynamic parameters of a drug.

Services include:

• Developing clinical trial computer models
• Simulation of various clinical trial designs to find the most effective one
• Population pharmacokinetic and pharmacodynamic scenario modeling
• Determining the optimal drug dosing

Web-based software helps to accelerate patient randomization processes by clustering and applying algorithms that can help to ensure treatment group balance. We can help you with developing software that can tackle randomization, blind management and clinical supply administration.

Services include:

• Defining complex randomization scenarios
• Randomization checks and email alerts
• Traceability of clinical studies, patients and results
• Software developing for Investigational Medicinal Product (IMP) management from shipment to replenishment  
• Configuration of treatment allocation and randomization types

Machine learning methods are a superpower for drug discovery that helps to extract more information from scant datasets. Avenga can build you a tailored probabilistic model, so you can make predictions for future clinical trials from it.

Bayesian sequential approach for clinical trials helps to:

• Reduce the number of patients needed
• Accelerate the clinical trial completion timeliness
• Define the probability of early success or failure
• Quickly produce high-quality evidence

Virtual clinical trials shift the way clinical trials are performed by utilizing novel technologies which simplify the subjects’ experience. Decentralization of clinical trials makes us think outside the box to connect technology and patient safety in the best way to meet the need.

We can help with developing digital solutions for:

• Online patient recruitment
• Online patient monitoring
• Online health check ups
• Online questionnaires
• Online document verifications

Delayed patient recruitment is the biggest reason and the hottest problem stagnating the success of a clinical trial. Natural language processing helps our clients gain insights on how to uncover hidden connections in the data and find investigators-influencers that can source large numbers of eligible patients for the trial.

Services include:

• Named entity recognition
• Topic clustering
• Keyphrase extraction
• Multi-document summarization
• Relationship extraction

iOT devices like wearables, smartphones, and in-home health devices enable precise patient monitoring and enhance the flexibility of clinical trials. iOT devices equip companies-sponsors, investigators, and subjects with innovative insights and analytics that can drastically change the way we receive healthcare. The data obtained from iOT devices helps life science companies to make better decisions and gain a competitive advantage.

We can help with developing digital solutions for the following iOT use cases:

• Remote patient monitoring
• Immediate adverse reporting
• Emergency notification systems
• Better data collection   

Early detection and assessment of adverse reactions secures patient safety. Automation, predictive analytics, natural language processing (NLP) and machine learning (ML) technologies can help to improve compliance and drug safety.

Avenga can help you with:

• Developing algorithms for adverse event detection, validation and reporting 
• Identifying adverse events from unstructured data
• Developing solutions for swiftly managing adverse reports in multiple languages and in high volumes

We provide assistance to CROs on the different regulatory and institutional review committees to ensure the success of the clinical trial. Avenga can support your regulatory information workflows and drive harmonization, standardisation and ensure compliance in order to be competitive on a global scale.

Services include:

• Integrated regulatory document management software development
• Sequence management and variation control platform development 
• Developing submission publishing software
• Deploying 21 CFR Part 11 compliant systems
• Preparation for the new EU Clinical Trials Regulation that goes into force at the end of 2021