Although clinical trials management systems (CTMSs) are an established software field, a lack of adaptability to future clinical trial trends and integration with other key life sciences information systems has hampered any real improvements to operational efficiency and kept them as a disconnected silo within the overall clinical process.
“This is an area with scope for considerable improvement, especially as blockbuster drugs give way to more specialised medicine including therapies for rare diseases and more personalised treatments,” explains Torsten Friedel, Managing Director of intilaris in Basel, Switzerland. “With smaller populations to recruit from, there is growing pressure on life sciences R&D organisations to deliver high-quality trials efficiently – not least to maximise the 20-year period of exclusive patent sales.”
intilaris is an independent consultancy and business process optimisation specialist. Through the partnership, the company will share its deep clinical development process expertise with Generis which will incorporate new clinical trials management capabilities as part of its integrated life sciences content management platform, CARA™.
Crucially, users will be able to access and manage a wide range of information from a single system.
“Instead of looking between three applications to tie everything together, everything will be visible via a single window,” Torsten notes.
Currently, clinical development planning processes are managed in a largely manual way, using static documents whose data is hard to integrate and coordinate with other functions and processes.
Adding CTMS functionality to the CARA platform will make it easier to unlock this information and view and combine it with other process information.
For instance, up to now it has been hard for clinical teams to get a clear view where and when patients have been recruited, and link this information to the logistics for distributing trial kits – because recruitment and logistics have been managed separately. CARA’s integrated approach will enable a clear line of sight across related activities, driving greater efficiency.
“We are delighted to be entering into this partnership with intilaris LifeSciences,” says Max Kelleher, Chief Operating Officer at Generis. “The aim is to deliver step improvements in clinical trials efficiency, drawing on intilaris’s deep subject expertise. We will build their clinical trials management best practice into our broader Life Sciences information management platform and, where companies want further help with process transformation, intilaris can provide that independent advice and design expertise as an additional value to our customers.”
The partnership will deliver something greater than the sum of its parts. “We focus on clinical development process optimisation, while Generis provides a great product spanning a whole range of life sciences functions,” Torsten says. “They bring the technology expertise and the regulatory understanding, while we bring a deep knowledge of clinical processes optimisations and bridge business and technology to help improve that.”
Where companies don’t want to distance themselves from core CTMS products they have already invested in, Generis will support a gradual transition towards greater process and data integration.
“This is not a ‘features and functions’ war,” Max notes. “It is about improving the way clinical trials are managed by breaking down information silos and improving process visibility.”
The intilaris relationship is the latest strategic partnership for Generis, which has also recently announced a collaboration with submissions management solutions and services company, Qdossier. Qdossier has selected CARA from Generis as its RIM and content management system and search engine, underpinning a new cloud-based solution and services offering for life sciences.
Generis is a UK-headquartered developer of world-class Content and Regulatory Information Management technology for regulated industries globally.
Eight of the top 10 global life sciences companies rely on Generis’ flagship Intelligent Content Services platform, CARA™ for critical document and information management, including AbbVie, AstraZeneca, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.
Today Generis serves more than half a million users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com
intilaris LifeSciences GmbH is a Swiss consulting and service company optimising drug development through structured information and content-driven processes for the pharmaceutical industry.
intilaris implements, introduces, and delivers content and data-driven processes, leading to higher productivity in drug development. Tomorrow’s medicines cannot be developed with yesterday’s processes – more at https://pharma.intilaris.com/
Press Contact for Generis
Carina Birt, Sarum PR
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