Services Clinical Development Early Stage

Data Management

Scroll down for details
Tailored Data Management: Shaping Solutions for Your Unique Needs

At Accelsiors, we understand that each project is distinct, requiring personalized data management solutions. Our approach involves customizing every aspect, from the Electronic Data Capture (EDC) system to data validation procedures, ensuring alignment with your project’s specific therapeutic area, study design, data volume, type, and regulatory requirements. Our goal is to provide you with the most efficient and effective data handling for seamless collection, processing, and reporting. With Accelsiors, you can trust that your data is not just managed but leveraged, paving the way to your project’s success.

Our data management team at Accelsiors is seasoned in the use of a broad spectrum of Electronic Data Capture (EDC) solutions. This robust experience enables us to identify the optimal EDC platform for your specific clinical study.

In tandem with our chosen partners, we provide Interactive Response Technologies (IRT) for randomization and clinical supplies management, eClinical Outcome Assessment (eCOA) solutions, eConsent, eVisits, and more. These dynamic tools cater to the management of complex international clinical trials, whether they are incorporated directly within the EDC tool or seamlessly integrated through API connections.

Our team of database designers hold full certification in various EDC solutions, such as Zelta (formerly Merative CD/IBMCD), Oracle Clinical One, Viedoc, Medidata Rave. Additionally, if preferred, our Data Managers are equipped to work on any EDC platform of your choice.

Merative™ (prev. IBM Watson Health™)
Clinical One Platform (Oracle™)
Or we can perform our DM activities on any EDC platform of your choice ...

Our EDC solutions not only adhere to FDA CFR Part 11 compliance but also boast full validation. We ensure the deliverables are completely in line with CDISC standards, from CDASH to SDTM mapping. Coupled with a risk-based approach to clinical monitoring, we ensure efficient project delivery without ever compromising patient safety or data quality.

At the heart of our operations, our Data Center offers central monitoring oversight. Operational and clinical data trends are actively monitored and readily available to you in real time. This centralized data surveillance safeguards the efficient and effective management of trial risks and guarantees you have the most current information on your trial at your fingertips.

Prioritizing Data Security: The Core of Our Data Management Strategy

At Accelsiors, we place the highest priority on data security. Our systems are designed to ensure that your data is fully protected at all times, while remaining accessible to authorized personnel for necessary management and oversight tasks. Here are some of the key measures we take to secure your data:

  • Compliance with Regulatory Standards: We ensure that our data management practices are compliant with all relevant regulatory standards, including the FDA’s 21 CFR Part 11 requirements, which govern electronic records and electronic signatures, and the EU’s General Data Protection Regulation (GDPR).
  • Data Encryption: Data is encrypted both at rest and in transit, using strong encryption algorithms. This means that even if someone were to gain unauthorized access to the data, they would not be able to read it.
  • Access Controls: We implement strict access controls to ensure that only authorized personnel can access the data. This includes the use of secure authentication methods and regular audits to ensure compliance.
  • Regular Audits and Penetration Testing: We perform regular audits and penetration testing to identify and fix any potential vulnerabilities in our systems.
  • Secure Backups: We perform regular backups of all data, and these backups are stored securely to protect against data loss.
  • Incident Response Plan: In the unlikely event of a data breach, we have an incident response plan in place to quickly identify and mitigate the impact of the breach.

In short, we take data security very seriously and implement a range of measures to protect the data entrusted to us.

Data Management
Precision in Data Translation and Compliance: A Path to Excellence

At Accelsiors, we prioritize precision and adherence to standards. Our meticulous approach involves a clear translation of protocols into CDISC-compliant data structures, supported by efficient data validation and review tools.

We keep a pulse on the latest trends in clinical data management best practices and regulatory guidance, applying them across our systems and processes. Our dedicated mission is the generation of high-quality data, maintaining data integrity at every step for precise statistical reporting and subsequent analyses. All our processes are thoroughly documented and compliant with regulatory requirements.

By implementing an integrated data review system and a Central and Risk-based approach to clinical monitoring from the First Subject First Visit (FSFV), we ensure efficient project delivery. We achieve this without ever compromising on patient safety or data quality, demonstrating our commitment to excellence in every aspect of our work.

Moreover, we are proud to share one of the recent recognitions for our accomplishments.

In 2020, Accelsiors’ Data Management Team was nominated by the Association for Clinical Data Management and won the ACDM 2020 Annual Awards in the category of ‘Team Excellence in the Management of Clinical Data Award’.

ACDM has recognized our team’s strong knowledge and expertise in Clinical Data Management, the implementation of a new EDC platform, and more importantly the development of one of the highest performing teams in the company.

We’re thrilled to highlight a noteworthy achievement that showcases our dedication to excellence. In 2020, Accelsiors’ Data Management Team was not only nominated but triumphed at the ACDM 2020 Annual Awards, securing the prestigious ‘Team Excellence in the Management of Clinical Data Award’.

This prestigious accolade from the Association for Clinical Data Management stands as a testament to our team’s in-depth expertise in Clinical Data Management. It acknowledges our success in implementing a new EDC platform and, most significantly, it recognizes the development and performance of one of the highest-achieving teams within our company. This recognition fuels our commitment to constantly elevate our performance in serving our clients’ needs.

Let us accelerate your clinical drug development program!