Effective Clinical Data Management provider for clinical trial

Clinical data management is one of the most important project’s parts. Any challenge arising in this area can cause a lot of delays and difficulties with information processing. Nowadays, specialized companies services are being used widely because of considerable amount of knowledge they have in Clinical Data Management field. These companies create practical tools and procedures that are intended to guarantee correct data collection in clinical trials.

What are the types of activities performed by specialized data management CRO?

Clinical trial materials audit and CRF accuracy checking.

Sometimes CRF may happen to be inconsistent with study Protocol and statistical analysis plan (SAP); this lead to the collection of data in wrong format, units or even frequency, this can cause a lot troubles in statistical treatment. At this point, the audit can reveal inconsistencies and prevent data omissions at the earliest stage.

Proper selection of data collection tools.

Specialized data management vendor can consider electronic databases, eCRF, CTMS and other forms of electronic data collection systems. Electronic data collection tools have proved their efficiency, so CRO will identify and recommend the most appropriate tool to use.

Data entry.

In the case that data is not collected through the electronic system, formatting may be required to allow statistical processing. In such a situation, Data Management Company is forced to perform double independent data entry which leads to the creation of a clinical database.

EDC-related experience.

Apart from managing electronic data collection, specialized CRO can also configure and validate collected data. 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?

1. 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.
2. 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.
   • Read more in out article about Two main types of EDC systems
3. 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.
4. 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.
5. Data security
   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.