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| Natalia Fetkovska MD, PhD, Senior Partner, SanaClis s.r.o, a sponsor company at the marcus evans Evolution Summit 2015, discusses why pharma and biotech companies should consider working with CROs that have formed an alliance. |
NEW YORK, N.Y., May 1, 2015 - (ACN Newswire) - "Statistics show that more than 80 percent of pharma and biotech companies are willing to conduct clinical trials in emerging markets, however a number of them are unable to identify good quality contract research organizations (CROs) to work with in different countries," says Natalia Fetkovska, MD, PhD, Senior Partner, SanaClis s.r.o. Fetkovska suggests a novel solution as a new operational business model: working with CROs that have formed an alliance.
"Sponsors will save time and money. The clinical trial will go faster than if they had chosen to work with a large global CRO or many small local ones," she adds.
SanaClis is a sponsor company at the marcus evans Evolution Summit 2015, in Palm Beach, Florida, May 6-8.
- What is the current state of the CRO market?
The cost of clinical research and drug development keeps rising, while the quality and regulatory requirements are more stringent than ever. Traditional CROs and sponsors are under pressure to reduce costs, while higher quality and greater effort is being required of them.
Thus, sponsors are looking for cost saving opportunities and new operational models. Many are outsourcing their clinical research programs to global CROs, others to small single CROs, which can be costly to manage. Working with several partners makes the logistics and management of the trial more demanding in respect to time, sponsors' resources and costs.
- What is the CRO alliance model and why should sponsors consider working with such an alliance? Can it bring on any competitive advantages?
It provides companies the chance for cost savings without the loss of competencies and quality. Alliance as a business model is not new, but CRO alliances are quite rare. There are mergers in the CRO industry. The difference is that with an alliance each partner retains its independence as a legal entity, while SOPs, quality management, project management and any project-specific requirements/processes are standardized and joint/united in one.
By joining their efforts, CROs provide greater country coverage and additional services to customers. The alliance multiplies their individual abilities. Another advantage of utilizing small CROs in an alliance instead of global ones is their flexibility, local knowledge and know-how.
Sanaclis - instead of opening new offices in additional countries works in alliance with CROs which were qualified by us and meet our quality requirements. This leads to lower costs of clinical trials and a competitive advantage for all parties involved.
- Why do sponsors have difficulty in finding reliable small CROs in emerging countries?
There are so many CROs. Some very competent, high quality, small CROs cannot afford expensive business development activities to stand out in the crowd, but an alliance makes them more visible and easier to find.
If a sponsor decides to conduct a trial in an unknown or less known region, the choice is usually between a global CRO or small local CROs they are not familiar with. A better option would be a network of CROs that have formed an alliance, which would cost less than the other two options because of its flat structure.
- Could it also prevent drug development delays?
Yes, this could help companies prevent certain delays, reducing the cost of drug development. The CRO alliance will certainly go faster than several individual small CROs or a global one. The smaller a CRO, the faster, more flexible, dedicated and personal the deliverables will be. CRO alliance created per project has the optimal structure to achieve fast and high quality delivery.
About the Evolution Summit 2015
The 8th Evolution Summit is the premium forum bringing clinical trial experts from leading drug development companies and solution providers together. The Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development. Taking place at the Eau Palm Beach Resort & Spa, Palm Beach, Florida, May 6-8, 2015, the Summit includes presentations on improving trial performance, driving innovation, site selection and feasibility, and pinpointing recent trends.
For more information please send an email to press@marcusevanscy.com or visit the event website at www.evolutionsummit.com/NataliaFetkovskaInterview2
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About SanaClis
SanaClis is a contract research organization (CRO) offering a comprehensive range of services to support the drug development process in CEE region.
SanaClis Clinical, IP & CTS Management, Data Management & Biostatistics departments provide high quality services to support the clinical development of drugs and medical products. Regional knowledge, experience and the use of powerful and efficient validated equipment and CTMS, CDISC Certified & regulatory compliant EDC software suite and services of professional biostatisticians enable our team to deliver top quality data on-time, within budget and help to avoid delays in the clinical research process. Our clinical experts and statisticians work closely with the DM Team to meet the needs and objectives of each specific project, providing every time a customized service. SanaClis is an active member of the CDISC organisation. SanaClis also leads and manages CRO alliances on a project-specific basis. www.sanaclis.eu.
Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager, marcus evans, Summits Division
Tel: +357 22 849 313
Email: press@marcusevanscy.com
Topic: Trade Show or Conference
Source: marcus evans Summits
Sectors: Daily Finance, Daily News, BioTech
https://www.acnnewswire.com
From the Asia Corporate News Network
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