Efficient Clinical Data Management provider for clinical trial
How to choose CRO for clinical trial data management outsourcing
Clinical trial data management is one of the most important project’s constituents. Troubles in this area can cause a lot of delays and difficulties with information processing. Nowadays specialized companies services are used widely because of great volume of knowledge, gained in Clinical Data Management realm. These companies create practice, tools and procedures that is intended to guarantee the correct data collection in clinical trials.
What types of activities do such specialized data management CRO perform?
Clinical trial materials audit and CRF accuracy checking.
It is sometimes happened that CRF is inconsistent with study Protocol and statistical analysis plan (SAP). Sometimes this lead to the data collect in wrong format, units or frequency and it causes troubles for statistical treatment. Audit can reveal inconsistencies and prevent data omissions at the earliest stage.
Proper data collection tools selection.
Specialized data management vendor can consider electronic databases, eCRF, CTMS and other types of electronic data collection systems. Electronic data collection tools have proved their efficiency, so CRO will identify and recommend the most appropriate tool.
On the chance of data was collected not through electronic system, it is needed to perform format, suitable for statistical processing. In this case data management company performs double independent data entry so clinical database is created.
Specialized CRO have to manage electronic data collection systems as well as to configure and validate them. Ideally, CROs should get their own data collection system. This allows team to realize the possibilities of the system, to configure and validate it correctly for each specific project.
What should we take into consideration choosing Clinical Data Management vendor?
Processes and procedures standardization
For every data management stage there is a standard operation procedures kit. There is a separate accounting document and the responsible person for each given stage. Thereby it helps to build smooth data management procedures to avoid losses and omissions during data entry and clinical database management process.
The type of EDC system, which is provided by CRO
Today two types of clinical data management services exist. First type is a non-preconfigured platform, which should be tuned in accordance with the protocol and CRF. Such systems can be cheap, but overall usage cost is significant, since configuration of system and CRF is a huge task.
Second type of EDC system are ready-to-go EDC systems, which configures in accordance with Protocol and paper CRF. This type of electronic systems is more expensive, but Sponsor gets completely and consistently configured and validated system, that is ready to use.
It is important to reveal the volume of CRO’s responsibility (developing, configuring, tech support) in advance.
System validation and testing procedures
To collect all necessary data in a proper way, EDC have to be thoroughly tested and validated. Please make the request on validating procedures and relevant documents which are usually provided after the system shifts to production mode.
System usability and trainings
According to Tufts Center for the Study of Drug Development interview, 77 percent of all EDC system users have problems with data entry. That is why it is important to assess usability and features of the system. Be aware if trainings for users will be provided by the vendor of EDC system.
When you will have the selected EDC system, it is important to know what measures were taken to prevent unauthorized access to data, is there data encryption, data backup and disaster recovery plan. Before signing agreement with CRO, it is needed to know where clinical trial database is stored, who has access to the system after database closure and is there a possibility of database backup in case of data losses.
Our clinical trial data collection and data management system is one of the most progressive clinical software on the market. During the years of development, we develop unique features and efficient working solutions. Thus it takes us a couple of weeks to deploy and configure the system for clinical database management.
OnlineCRF configures by dedicated project team according to each study protocol. All development processes are based on standard operation procedures, which is fully compliant with GCDMP.
Clinical trial database is stored on several protected servers in different parts of the world. Thereby data can be restored even due to significant damages of one of those servers.
OnlineCRF has got an easy and user friendly interface. Simple data entry workflow helps investigators to be efficient. We are one of the few CROs, which covers of all stages of system configuration and validation. After configuring OnlineCRF our specialists conduct trainings for Sponsor representatives. We stay in touch during data collection period and provide you with a full range of supporting services.