In the management of the clinical trials we basically use SAS Software in data management and reporting. In sample size calculations sometimes R or PASS is also used beyond SAS software. Our eCRF system was programmed basically in PHP and some other tools were used (e.g. R, JavaScript, etc.). Our web-based solutions were created in PHP with integrated R or R/Shiny solutions. Clinical databases are stored in SAS internal datasets or MySQL databases. But there is no restriction in this, our systems are able to connect to any commercial database system.
eCRF
When we started in 1997, everybody ran paper based clinical trials. The concept of electronic data capture was determined and Planimeter was among the first companies to provide an electronic way for data collection.
Our solution has been successfully implemented in more than 10 countries during the last five years and it turned out to be a valuable solution for data collection in clinical trials.
FDA (Food and Drug Administration) also let out a check list to adjudge the 21 CFR Part 11 compliance of a system and I can declare that our solutions fulfils that requirement, too.
Our eCRF fully represents the Investigator’s expectation to work in a self-evidently simple system without unrealistic checks and application. When we developed this system we were absolutely aware of documentation demands of a clinical trial. This concept was fully integrated into this system and this solution leads to a 98% satisfaction with respect of system usage.
But we are a statistical team and we were quite aware of clinical trials when we started to develop our solution for data collection. The system was tested so far in 27 studies and 14 countries and all feedback emphasised the simplicity of the system. We are not surprised to hear that but we are proud of that.
The eCRF can cover all the usual required activities:
- Randomisation
- Query management
- (S)AE reporting
- Derivation of printed versions for archiving purposes.
eTMF
Electronic Trial Master File is essentially a document repository, which is extended with strong (but flexible) project control
All study-specific data can be uploaded and stored in this environment. The current version is the mapping of the TMF reference model 3.2.1 https://www.scribd.com/document/520152543/Version-3-2-1-TMF-Reference-Model-v01-Mar-2021 While the system creates a standardised environment, the framework renders possible a 100% level of personalisation in the menu systems, which is the scope of the managed documents.
Szajkó
Our e-learning system
Every company has a wealth of knowledge as great as the sum of its employees’ expertise and knowledge. It is therefore vital for users to value, use and continuously expand this knowledge.
An eLearning system was developed for internal usage in 2011. We are audited regularly by our clients and we expected to complete the internal training documentation isse. It really solved this problem and it turned out to be such a generally good solution that one of our clients started to use it – in 2014.
By today it turned out that this system is one of the most valuable in our portfolio. It is able to cover the eLearning demands of companies of any dimension (we already have experiences from collaboration with companies of 2000-3000 employees/contractors).
It also turned out that the two most valuable features of the system, namely strict versioning and a well documented process control makes this solution highly competitive for pharmaceutical companies.
We started to develop an e-learning system which is being transformed into a training platform. What is the difference? The system today is much than set of training materials. It also contains the opportunity to define tons of automatisation processes to manage the whole training process. Furthermore, it is connected with HR at many of our clients, so an on-boarding process or switch in position can also be automatically detected and follow-up.
In e-learning basically there are two options:
B2C: Your client will educate its own employees, contractors. In that case integration with HR is a good solution to support the efficacy of the system
B2B: Your client will educated its clients’ employees, contractors. In such situations other features, like measuring the exact system usage on different scales might be high importance.
Our – otherwise – SCORM-compatible solutions is a perfect solution for both cases.
For details visit: www.uzletioktatas.hu
Automated
Reporing
Do you have a regularly repeated reporting activity? Do you have to make the same calculation week by week? Are you suffering from a constant time pressure with updating yout reports just because the input data arrives late?
If so, you have to try to automate your reporting tasks.
Report automation means that the input sources of the output is processed by a computer program, which creates the required document. This is highly beneficial procedure but if and only if a report template can be defined.
Templates are typically used internally, when there is a reporting procedure in which the weekly/monthly obtained data should be analysed and interpreted. But external reporting demands can also be found in high number where the different data are arranged in the same format.
In clinical research both Statistical and Clinical Reports have their strict templates. Automation of this type of reporting can be crucial in gaining time: if the template is ready to use, the report can be generated from the clinical data wihin minutes. Another important benefit shows in quality. No typos are expected – as there is no direct typing.
Business can also profit from this digital transformation tool. We all use IQVIA-services for marketing-sales purposes in the pharma industry. You can legally buy sales data collected from pharmacies – of your competitors’ products, too. IQVIA has a very wide range of services. Simplifying it: having a subscription, you will get a new database in each month.
You have the full freedom to analyse the data and distribute the reports. Preparation of a RTF, Word or PDF documents from this data is not a technical challenge.
But with a good portion of data scientist analytical approach, the value of the raw data can be easily doubled. The background processes can be revealed and quantitatively described.
Finally the best practice in harmonizing automated reporting and sophisticated data analysis is implementation of a web-based dashboard. With setting up a dashboard, you increase the speed of information distribution to the maximum. Furthermore, you can easily control the quantity of the shared information – also automatically – with a proper set-up of the access level.
