The development of a new pharmaceutical compound takes between 8 to 12 years and costs up to US $1.7 billions. The process includes the development of the compound, preclinical testing, clinical studies and the final approval. Clinical studies are the key element of this process. Half of the financial and temporal input is applied to them. In order to stay competitive, pharmaceutical companies need to introduce about four to five compounds to the market each year. Therefore this key role also becomes the bottleneck of the development process. Nowadays, the challenge is to speed up clinical trails and with that the registration of new compounds. A major barrier to achieve this goal is the manual recording of the study data on paper. However, currently 95 percent of the studies are still recorded on paper. This procedure holds significant disadvantages and risks:
- The complex data collection causes delays of several months until the data is available.
- The plausibility check of the data is very time and cost consuming
- Wrong or missing data cause a great number of additional inquiries
- Weak points might not be uncovered until months afterwards
This indicates that the classical way of data collection will not achieve the necessary acceleration of clinical trails. One way to avoid these problems is the electronic data capturing (EDC) during clinical trails. The direct data capturing, immediate plausibility checks as well as the real time availability of the data solve the problems of classical studies. By using EDC, clinical trails can be conducted faster and in consequence the new compound will be approved sooner. The use of electronic data capturing does not only save time, it also improves the data quality and reduces the cost of a trail.
Clinical trials - products
Qualitype AG offers solutions for electronic data capturing (EDC) in clinical trials. The concept enables on-site collection of patient data and is adaptable to the daily workflow. It includes all advantages of electronic data capturing. The study data will be checked and is accessible immediately after the collection. It also supports many different standards and a smooth transfer into other systems. The customers use the systems in a validated environment. Therefore the products are designed according to the regulations and guidelines of GLP, GCP, FDA 21 part 11 and EMEA.
The product deploys latest technologies like JAVA and Microsoft C# within Microsoft .Net 2.0 framework and can so be constituted on all platforms in future.
The implementation of our EDC solutions simplifies and accelerates the data collection during clinical trials. This allows a faster realization of the studies and save time and money.
