In the world of clinical trials and maximizing the key outcomes possible, Data Management and Biostatistics are two critical components that often intersect. From data collection and validation to ensuring compliance with regulatory requirements, the complexity of these services requires a specialised team with both experience and a deep understanding of the technologies and methodologies involved.
At Accelagen, we provide comprehensive Biometrics support that integrates data management and statistical analysis to ensure the accuracy and integrity of clinical trial data. This support is essential to the success of clinical trials, and understanding its value can make a significant difference in the efficiency and outcomes of your research.
The Scope of Biometrics Services from Accelagen
Biometrics in clinical trials encompasses a range of services designed to collect, manage, and analyse data efficiently and accurately. A key function that underpins study quality is developing a robust and effective study database that is able to capture all the information required within the clinical trial protocol. This includes setting up case report forms (CRFs) that are used to collect data, such as Medical History, lab results, and other trial-specific data.
Another important aspect of study conduct involves the application of randomisation of study participants. If the trial requires random assignment of participants to treatment or comparator groups, we ensure that the randomisation specification is not only appropriate, but ensures statistical validity.
At Accelagen, we work with various stakeholders—including external lab vendors and pharmacokinetics (PK) experts—to bring together diverse data sets in a way that supports accurate and timely analysis. This collaborative approach ensures that all data is ready for the statistical analysis phase, which is crucial for drawing meaningful conclusions from the trial.
The Competitive Landscape for Biometric Services
While there are many companies offering biometric services, Accelagen stands out through our highly specialised and experienced team. While larger teams may offer broad capabilities, the strength of Accelagen lies in the depth of experience within its smaller, dedicated team. Our database programmers, data managers, statisticians, clinical and medical teams work closely with clients to ensure that all aspects of the data collection process are aligned with the trial protocol.
This tight-knit, collaborative team is able to identify and address issues early on, ensuring smooth trial operations. Unlike larger organisations where departments can become siloed, Accelagen’s integrated approach ensures that all team members, from data managers to clinical teams, work together seamlessly to resolve challenges and maintain the integrity of each sponsor’s data.
Common Challenges in Data Management Accelagen Helps Customers Avoid
One of the key challenges in data management within clinical trials is ensuring that all data is collected and entered correctly. Issues such as missing data, incomplete forms, or even technical failures like login issues can disrupt the trial process. At Accelagen, our data managers are in constant communication with the clinical team and trial sites to identify and resolve these issues as quickly as possible.
Although we all do everything possible to avoid them, protocol deviations remain common in clinical trials. These deviations can range from missed assessments to variations between what was planned in the protocol and what occurs in practice. By closely monitoring the data collection process, our team ensures that all deviations are reviewed, documented, and actioned as required, further ensuring data integrity is maintained.
Why Choose Accelagen?
In many cases, organisations might consider handling biometric support in-house. While this might seem like a cost-saving measure, the complexities involved in setting up and maintaining a clinical trial database can be overwhelming. With Accelagen, you benefit from a team that has the technical expertise and experience to set up databases compliant with CDASH (Clinical Data Acquisition Standards Harmonization ) standards from the start. This ensures that datasets comply with regulatory requirements and are optimised for effective statistical analysis in Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) format.
Additionally, as clinical trials evolve, the methods of data collection are becoming more advanced. From electronic patient reported outcomes (ePRO) and eDiaries where information on symptoms, self-rated questionnaires or tracking a daily activity such as dosing can be recorded directly using a tablet device or mobile phone, the landscape is changing rapidly. Accelagen is equipped to handle this new wave of data, ensuring that all sources of information are integrated seamlessly into the trial database.
The Accelagen Difference: A Focus on Clean, Valid Data
What truly sets Accelagen apart is our commitment to delivering clean, valid, and robust data. Our team is dedicated to ensuring that your clinical trial data is as accurate as possible, from initial collection to final analysis. This focus on data integrity is not just about meeting compliance standards—it’s about ensuring that your trial results are meaningful and can stand up to scrutiny, both scientifically and regulatory.
Our approach is collaborative and client-centric. Whether you’re a small biotech getting a foothold in the clinical study stage of development, or a larger organisation with more established processes, we adapt to your needs and provide the necessary support to guide you through every phase of the trial. From data collection and randomisation to statistical analysis, we work with you to ensure the success of your clinical trial.
At Accelagen, we understand that the accuracy of your data is crucial to the success of your clinical trial. By providing comprehensive Biometric services, we ensure that data is collected, validated, and analysed in accordance with industry and regulatory standards and trial protocols. Whether you’re looking for a partner to guide you through a complex clinical trial or seeking expert help to manage your data more effectively, Accelagen offers the experience, dedication, and expertise you need to achieve success.
If you’re ready to learn more about how Accelagen can support your clinical trials, get in touch with us today.