Novellas International offers pharmaceutical, biotech, medical devices companies, CRO’s and hospitals an unique innovative solution, aiming to improve the planning and execution of clinical trials through the creation of Centers of Excellence in Clinical R&D and thus decreasing related time, costs and risks. We provide our clients a very high level of practical experience, know-how, contacts, and confidentiality to create substantial added value and increase return on investment.
This goal will be achieved by providing support and expertise to establish high-quality clinical R&D resources and processes, starting from existing local-regional infrastructure and needs in order to develop a network of Centers of Excellence in Clinical R & D.
We understand the challenge of managing a clinical research center that can deliver high quality data.
Our concept is based on a solid methodological approach.
How :
To achieve high quality standards at the investigational sites is a very challenging task that demands a holistic approach, combining clinical research expertise, process based thinking and management of good practices.
Assessing sites – analyzing opportunities – defining what must be done – managing change and translating opportunities into an operational roadmap to excellence based on a proved methodology (Lean Six Sigma), can effectively overcome the challenges.
The creation of Centers of Excellence in Clinical R&D improves the organization’s capabilities and will set it apart from the competition through higher quality standards in the performance of clinical research.
Clinical studies present numerous legal and operational challenges, which become even more complicated when trials are conducted abroad. Unforeseen delays can shorten the period during which a product can be commercialized before patent protections expire. In the current economy, increasing the value obtained from each dollar spent and maximizing the return to investors is crucial.
Some facts:
According to separate studies conducted by McKinsey Quarterly and IBM Global Industries, more than 80% of all clinical trials experience significant delays costing pharmaceutical companies upwards of $35,000 per day, per trial.
For a drug destined to make half a billion dollars in annual sales, a one-day delay costs about $1.3 million.
The potential for success of a new chemical entity at the beginning of Phase I is still only 10%.
Nearly 90% of clinical trials are completed with significant delays.
A clinical program may involve as many as 80 different clinical trials, however only 20% of these studies might actually be on the critical path. On the grand scale, it is obvious that any delay in any study on the critical path would lead to a delay in the completion of the entire development program. Since close to 90% of clinical trials experience a delay, not a single program completes on schedule.
Slow enrollment is the number one reason for the failure of clinical trials. Eighty-six percent of studies slip behind schedule. Furthermore, 60% of studies have delays of at least one month and 13% of studies are completed six months or more behind schedule. With most clinical trials on the critical path and each individual trial incurring months of delays, the overall development program can be delayed for years.
Calculating the Return On Investment (ROI)
The creation and development of a network of Centers of Excellence in Clinical R&D will leverage the clinical trial performance by reducing costly delays and allowing a better planning of the clinical trial. Direct costs can also be reduced and net present value of the product will be increased. We provide a more effective way of planning for all staging during the trial, giving our clients confidence and predictability in its study timelines, from site feasibility to data lock.
A Center of Excellence will be able to reduce trial lifecycle up to 20% and to provide deeper insights in the site’s performance to positively impact the planning of the trial allowing the sponsor to improve the planning of the trial by integrating scenario analysis techniques and contingency plans.
We have analyzed the present market situation on clinical trials and believe the following objectives can be achieved through our unique concept of Centers of Excellence in Clinical R&D:
- Reduction of delays in clinical trials up to 20%
- Improvement of the site qualification process through a more effective predictability of the site’s performance
- Improvement of the clinical trial quality
- Reduction of direct costs related to the trial through a more effective and efficient planning and resource allocation
While most of the solutions on the market are focused on isolated parts of the problem, we are the only company providing a holistic solution based on creation of Centers of Excellence in Clinical R&D and focused on consistency with the regulatory environment, predictability based on standardized processes, change management to manage people’s behavior and continuous improvement.
