Dokumeds conducts clinical studies with BSI CTMS
International CRO selects CTMS solution from BSI
Dokumeds, a dynamic Clinical Research Organisation (CRO) with nine branch offices in Eastern Europe and partners around the globe, has chosen BSI as its CTMS partner for the conducting and administration of clinical studies.
The solution is based on the BSI CTMS Standard 5.5 and covers the entire range of study planning and supervision, including monitoring, patient tracking and document administration (eTMF). An upgrade to the next BSI CTMS Standard 5.6 shall follow in a second release, which will be expanded to HR Management, Business Development, Activity Planning and Tracking, including offer generation and billing, turning BSI CTMS for the CRO Dokumeds into a complete “ERP system”.
“BSI convinced us as trustable company with a highly developed standard solution, maximum flexibility, compliance to industry standards, integration possibilities and a good price-performance ratio,” said Indra Aboltina, CEO at Dokumeds.
“BSI convinced us as trustable company with a good price-performance ratio.”
Indra Aboltina, CEO at Dokumeds.
The main users of the solution will be 150 clinical monitors and clinical project managers. BSI CTMS will provide Dokumeds with a real-time online overview of all studies, patients and activities.
“With BSI CTMS we are replacing our heterogeneous system landscape and making a significant step towards a paperless clinical trial management process.”
Laura Jekabsone, Project Manager at Dokumeds.
“BSI CTMS will reduce time and efforts for keeping the overview of operational data on different levels. Through providing data for a digital dashboard for trial managers faster, the system will facilitate the early risk assessment and decision making process and support the efficiency across operations.”, explained Laura Jekabsone, Project Manager at Dokumeds.
Interview with Indra Aboltina: How the company is moving towards digitalization.
How will the introduction of CTMS improve the collaboration between Dokumeds and its sponsors?
For the currently used management tools, information must be gathered from various sources and systems involved in clinical trial management, which is time consuming. By launching CTMS we are improving oversight of trial performance, providing quick and easy access to actual versus target milestone comparisons across the site, trial and company levels. Comprehensive reports in CTMS provide an overview of information that facilitates early risk identification and emphasis on focus areas to ensure delivery of the expected results and milestone attainment.
Which role does CTMS play in the context of CRO-pharma collaboration?
Introducing a robust system to manage clinical trials enables Dokumeds to improve its service and quality. Data transparency, interaction and easy trial progress control and the option of providing sponsor access to the operational data will all benefit the Dokumeds-sponsor collaboration.
How was the CRO-pharma collaboration previously organized?
While the existing clinical trial management tools enable gathering of the required data and trial progress control, there is improvement potential in terms of resource effectiveness. Implementing a system for clinical trial management tailored to Dokumeds’ needs provides added value to Dokumeds’ services, making them more attractive to sponsor companies. With the CRO CTMS platform it is possible to provide the sponsor access to the operational data.
What is Dokumeds trying to achieve?
Dokumeds aims to maintain and increase its present business volume by providing operational flexibility. Introduction of CTMS and tools streamlining online and offline data exchanges improves the generation and handling of data, documents, as well as providing timely access to accurate and up-to-date information.
What opportunities and challenges do you have?
Managing trial timelines and compliance with the milestones can be challenging without an effective reporting system. Having all trial-related data in CTMS enables easy tracking of timelines and achievement of the milestones, providing the project manager and company management the oversight needed to direct attention and allocate resources towards areas of risk.
What business benefits does Dokumeds expect to attain with the new system?
Real-time oversight of trial progress, issues and possibilities permits more efficient trial planning and conduct. The input of each team member is essential for reaping the benefits that the system has to offer.
CTMS User Group Meeting in Zurich
“We are pleased to have a growing customer base in the CTMS field. The cooperation and close exchange with our customers are driving the product forward and contributing to the professionalization and boosting of efficiency for the entire industry,” explained Jan Klint Nielsen, CTMS expert at BSI. He will introduce the new BSI CTMS Standard 5.6 together with Dokumeds at the CTMS User Group Meeting on November 16-17, 2016 at the Gottlieb Duttweiler Institute in Zurich. The product roadmap for 2017 will be discussed and coordinated together with many existing and potentially new BSI CTMS customers. It is essential to involve customers in the definition of the future functionalities of the CTMS. It is also a great opportunity for the BSI CTMS customer community to share their knowhow and experiences. Register now