By Nadia Nahmany
Clinical trials are a critical step in the drug development process, and the effective management of data plays a crucial role in their success. After all, data forms the building blocks of information used to evaluate the safety and efficacy of new drugs and medical devices. The FDA, for example, outlines its expectations regarding data quality in its21 CFR Part 11 guidance, which recommends the creation of records that are attributable, legible, contemporaneously collected, original to the source, and accurate (i.e., free from errors, complete and within ranges).
Clinical research generates an enormous amount of data at every stage of the trial cycle, and a considerable amount of time and effort must be invested into each piece of data to ensure the success of collection, processing, and quality control procedures. To manage these data management processes effectively, pharmaceutical companies often rely on multiple vendors. However, managing large amounts of data from multiple vendors and ensuring compliance with regulations can be a complex, time-consuming, and expensive task, especially when the company lacks in-house expertise in clinical data management. Hiring a Clinical Data Management (CDM) Consultant can provide a solution to these challenges and enable companies to bring new drugs to market more efficiently.
Here are 5 reasons why pharmaceutical companies need a Clinical Data Management Consultant.
To ensure compliance with regulatory guidelines: Pharmaceutical companies are required to comply with strict regulatory guidelines when conducting clinical trials. A CDM consultant can ensure that all data is collected, processed, and reported in accordance with these guidelines, reducing the risk of non-compliance and smoothing the regulatory submission process.
To optimise the data management process: Clinical trials generate an enormous amount of data that needs to be properly collected, stored, organised, analysed, and eventually submitted to regulatory authorities. This can be overwhelming for companies lacking in-house CDM expertise. It can also create fertile ground for mistakes. A CDM consultant can help to streamline the data management process, ensure that all data is accurate, complete, and accessible, and minimize the risk of critical issues throughout the duration of the study. Moreover, a CDM consultant can help sponsors select the right electronic data capture (EDC) platform for their studies by providing insight on critical features, technical nuances, and limitations.
To improve vendor management: Pharmaceutical companies often work with one or more external vendor to conduct clinical trials, such as contract research organizations (CROs), clinical laboratories, imaging services providers, and so on. A CDM consultant can help to manage these vendors, ensuring they are meeting the established data quality standards in a timely manner and within budget. A consultant can also serve as liaison, communicating the company’s needs to the different vendors and “translating” the sponsor’s requirements to the data management language.
To enhance cost savings: Proper data management can help to reduce costs associated with clinical trials. A CDM consultant can help to identify areas where data management processes can be improved and streamlined, leading to cost savings for the company.
To enable better decision making: Accurate, complete, and accessible data is critical for making informed decisions in clinical trials. A CDM consultant can help to ensure that all data is properly collected, processed, and reported, allowing companies to make more informed decisions about the direction of their clinical trials in real time.
Learn more about how working with a Bioforum CDM consultant can support your clinical trial needs.