Clinical Data Management: Why It Plays an Important Role in the Success of CRO Medical Research Services
The success of a CRO medical trial requires a high level of attention on accurate data creation and analysis. There are two main reasons why Clinical Data Management (CDM) is important.
– Ensuring comprehensive data of the highest quality is generated and analysed during clinical trials
– To obtain and protect medical records of participants involved in the clinical trials
How the Clinical Data Management (CDM) Process Works
With integrity being the key focus of a clinical trial management system, the Clinical Data Management process starts even before the study procedure is formalised.
The process commences with the design of a case report form (CRF). The form specifies what data needs to be collected, measurement tools to be uses and instructions for filling in the data fields.
Accompanying the CRF is a data management plan (DMP). This serves as a guide to support the activities which make up the Clinical Data Management. It includes the relevant compliance tools. Before the plan is put into practice, it is tested for data entry & validation, medical coding, discrepancy management database locking, medical coding and CFR tracking.
.Image/CDC
Although collection of data by CRO clinical trial companies can be done using printed forms, with evolving technology, there appears to be a greater preference for electornic data collection, which is both convenient and saves time.
A Data Validation Manual (DVM) is then developed. The document contains edit check programs to identify discrepancies during data cleanup.
A clarification request could be prompted as a result of data entries which have not been validated. This process is called discrepancy management. It investigates reasons for discrepancies so they can be resolved quickly.
This is important for CRO medical companies to ensure the clinical trial is not slowed down and timelines are met without ignoring data points or losing subjects. Electronic Data Capture (EDC) systems should capture any data changes to saved data and all discrepancies generated in an audit trail.
Discrepancies should be reviewed at regular intervals by the Clinical Data Management team members to ensure they are quickly resolved.
Coding of medical terms that have been reported allows for standardization of the data to be analysed and reviewed. This is very important in trials where multiple investigators are involved with the collection and reporting of information.
In the last part of the process, a database lock is installed once all data management activities are completed. In this way the CRO medical companies ensure no manipulation of study data takes place once treatment groups are identified.
Throughout the Clinical Data Management process, strict regulatory requirements are maintained by CRO medical companies to ensure all regulatory requirements are complied with.
Securing Clinical Data
Criminals and hackers are becoming increasingly aware that obtaining medical data is much more lucrative than credit card data. Unlike credit cards which can be cancelled, medical data is permanent.
Criminals also have a bigger window of opportunity to commit fraud using medical data. By creating fake IDs and forged documents, they can use medical data to buy drugs illegally and lodge false insurance claims.
The first step to secure clinical data is to ensure all critical information is accounted for. Clinical Data Management systems accomplish this by enabling medical companies to have better visibility over their clinical data from disparate sources. These include electronic health records present in information systems, public health data, and information from social sources and research partners.
Clinical Data Management solutions perform data analytics on huge amounts of data. Data analytics allow medical companies to process dissimilar information which can be easily integrated among applications. This results in easily applying security measures for dissimilar data.
Securing clinical data also has a huge impact on profitabliity for medical companies. These organisations spend millions of dollars on researching, developing and testing new drugs. Results of the clinical trials and testing are stored in their clinical trial records. If competitors are able to get these records, they can leverage the organisation’s efforts and introduce new medications first. This gives them a huge advantage over the competition.
Speed to Market
An often overlooked role which Clinical Data Management solutions play by enabling timely and accurate data to be analysed is to speed up decision-making processes.
Clinical Data Management solutions streamline data management processes such as data collection, filling case report forms, data entry, filing and tracking data and its validation. These improvements result in faster development, testing, and commercialisation of medical devices and drugs.
Author: Robert
