Data is one of the most important assets of an organization and is of great significance in the healthcare sector. Typically, healthcare entities rely on data entry outsourcing to manage the ever-growing amount of data. Consider its importance in clinical research, where the data must be entered in a timely manner so that it can be reviewed at the earliest. EDC (Electronic Data Capture) is a popular system today that helps to easily replace traditional paper-based data entry with electronic data entry to streamline data collection. EDC adoption also helps in reducing errors such as missing data or out of range values. But inefficient use of EDC can lead to failure of your valuable clinical investigation. So, it is important to work with a reliable vendor to ensure that your EDC system is used correctly to attain the desired results.
Clinical data management must be efficiently done, and the data presented must have integrity and trustworthiness to obtain the approval of regulatory agencies. Adherence to quality standards and practices is vital to gain the trust of regulators and remain compliant. Data management and the data extracted are essential to the overall clinical research function.
Following are some considerations to optimize the data entry processing your EDC platform.
Timely data entry ensures compliance: EDC system has integrated reporting tools that show the latest data entered into the system and assures that users have access to up to date reports about site metrics, enrolment, trends etc. Prompt data entry enables timely data review. The monitoring team has access to current information and can identify any systematic error. It also provides corrective action and training right away. With EDC system, the data management team has access to up-to-date site metrics and data extracts for analysis, and review. Decisions can be made based on timely and current data. EDC data entry at the right time is important for reporting an adverse event. Adverse events can range from an abnormal lab value to a life-threatening condition and the primary investigators must quickly assess the event and report it to the Sponsor. If data entry is delayed then your clinical investigation may miss an important deadline, misunderstand interim safety or cause a negative impact on the overall quality of service. So, it is important to update data in a timely manner and minimize the chances of non- compliance.
Enter all data promptly: One of the best advantages of EDC is that it allows entering data as soon as it is collected, and it can be reviewed immediately. This prevents the need to wait for paper CRFs (Case Report Forms) to be delivered via snail mail. Entering data as soon as it is collected is the best practice because data will be fresh in the mind and it can be shared between sponsors, data management teams, and monitors. Timely data entry helps to build confidence and improves quality and accuracy.
Given the importance of EDC, it will be worthwhile to look at the EDC market projection.
According to Stratistics MRC, the Global Electronic Data Capture (EDC) market is expected to grow considerably by 2022. Factors like improvement in information management and analysis, increasing product pipeline, improved compilation of technical and scientific data, increasing outsourcing by pharmaceutical and biotechnological companies and demand from EDC services are contributing towards market growth. Adoption of cloud-based services and use of fully integrated services will drive the market growth. Key players in the field are BioClinica, Clinical CLINIPACE, DATARANK International, Medidata Solution, Merge Healthcare, Omni Comm Systems.
Electronic Data Capture when done right, can ensure accurate data capture and management. It facilitates the data entry process. Data entry outsourcing is also a practical option for timely and efficient data capture and management.