CLINICAL DATA FOR
PHARMACEUTICAL
RESEARCH
TECHNOLOGY, STATISTICS & DATA MANAGEMENT
FOR CLINICAL TRIALS
We assist clinical trial teams to collect, manage and analyse their data. We develop our own cloud software systems, we have expertise in controlled clinical data management processes and deep know-how in statistical analysis.
CLOUD DATA COLLECTION
Our own EDC/ePRO/eCOA system, which we can quickly adapt to your needs, enrich with your requirements and which you have ready to use in the cloud. With real time monitoring tools to ensure data quality.
STATISTICAL ANALYSIS
Your statistical consultants at each stage of a trial, from inception, design and protocol to conclusive statistical analysis and reports for regulatory submission.
CLINICAL DATA MANAGEMENT
Our team of clinical data management experts can assist you in your clinical data management tasks. You can trust their experience in robust processes and compliance, and let them become part of your team to ensure data quality and minimise data risks.
CDISC
PROGRAMMING
We ensure your data are CDISC compliant, from CDASH and SDTM annotated CRFs to SDTM, ADAM and analysis scripts.
CLOUD TRIAL TOOLS
Interactive randomisation, clinical image assessment adjudication, real-time visualisation of any variable, lab data. Tools that can be quickly implemented according to your needs and efficiently integrated in your system.
REGULATORY
From an ICH compliant SAP to clinical study reports, efficacy and safety reports ready for regulatory submission.
OUR EXPERIENCE
We have worked with specialized CROs, sponsors, including most major multinational pharmaceuticals and innovative biotechs exploring new drugs, as well as with research institutes and academia, and international organizations and government bodies. We have provided technology, statistics and data management from small-scale but complex Phase I and II clinical studies, to demanding Phase III and meta-analyses for regulatory submission, to large scale, multi-centre, multi-country multilingual post marketing trials and patient registries.
Real-Time Endpoint Charts
Image-based Data Entry
Medical Image Assessment
Meta-analysis of pooled data
Dynamic delivery of PROs
Multi-country multilingual PROs
OUR COMMITMENT TO SERVICE QUALITY
REGULATORY COMPLIANCE
We are aware that our work affects the demanding regulatory compliance of a clinical trial and we are committed to adhere strictly to all relevant compliance requirements, from FDA and EMA guidance for Good Clinical Practice (GCP) to EU-GDPR legislation for data protection. Our documented SOPs are designed with compliance requirements in mind and our team is trained to ensure compliance in all aspects of our work.
STANDARDS
Applying technical and organizational industry standards has always been one of our most fundamental work principles. We can provide clinical trial data following the CDISC family of standards, from CDASH for data collection to SDTM for tabulations and ADAM for analysis. We prepare our statistical reports from SAPs to CSRs following the ICH E3 guidelines and our clinical data management SOPs implement the SCDM guidelines.
QUALITY & INFORMATION SECURITY
Our SOPs are part of an integrated ISO 9001 / ISO 27001 certified Quality and Information Security Management System which have been designed with GCP compliance in mind, specifically for the quality and information security requirements of clinical research, covering Cloud Software Services and clinical data management work, statistical analysis and statistical programming and software development, with particular emphasis on risk management.
ABOUT AGILIS
Agilis has been founded in 1998 with a strong commitment in technology and statistics. Since then we have developed innovative technological solutions for data intensive applications and provided in-depth statistics consulting to international organisations.
Our involvement with technology and statistics for clinical trials started more than fifteen years ago out of academic research projects and since then clinical trials have become our primary business and the focus of our technological and scientific strategy.
We have provided high quality services in dozens of countries in four continents, we have actively participated in international standardisation initiatives and we know how to become team members in the teams of our customers, rather than mere vendors or suppliers.
When using our clinical trial technology, you are actually recruiting an agile team of skillful software engineers, rather than just a license to use a software application.
Of course our applications, which you can use as cloud software services, are robust, validated and proven in demanding clinical trials. But we are always ready to adapt them to your very specific needs, develop new features and functionality for you or even to work with you for a new software tool.
In setting up your trials on our platform or implementing a complex custom functionality, you will work directly with our software engineers who will implement and test everything in close cooperation with you.
We do not provide mere “user support”. We know how to become your co-workers and share your commitment to the success of your trial.
Our team of highly qualified expert statisticians can provide you the reassurance of statistical robustness and quality from the inception stage of a clinical trial to its final conclusions.
From study design, sample estimation and randomisation, to the preparation of statistical analysis plans, to final statistical reports according to ICH standards.
Our statistical programmers can create validated programs for analysis, preparation of statistical reports and compilation of your ready for regulatory submission CDISC data files.
And we love non-typical tasks such as exploratory data analysis or intelligent algorithms to help you extract real valuable information from your clinical trial data.
Using our own applications, we can help you accomplish data management tasks of a clinical trial, according to Data Management Plans and Data Validation Plans we prepare.
We can help you with ad hoc custom reports and data extraction from the trials database, calculation of monitoring and risk indicators, and help you monitor the progress of your trial and identify risks and problematic cases and issues as early as possible.
Our data management team have years of hands-on experience in clinical trials and are the project managers of our clinical trial projects, being commited to ensure quality, timeliness and compliance. They work closely with our software engineers and statisticians to coordinate all our work for a clinical trial as an integrated project.
OUR ACHIEVEMENTS
We have worked with specialized CROs, sponsors, including most major multinational pharmaceuticals and innovative biotechs exploring new drugs, as well as with research institutes and academia, and international organizations and government bodies. We have provided technology, statistics and data management from small-scale but complex Phase I and II clinical studies, to demanding Phase III and meta-analyses for regulatory submission, to large scale, multi-centre, multi-country multilingual post marketing trials and patient registries.