No matter the size of the organization – from large pharma to virtual biotech – it’s critical to know that you have immediate access to expertise from your CRO. Large pharma’s need for expertise tends to be very specific, including an occasional need to bring in outside assistance if its own staff is overburdened. Conversely biotech’s needs can often be broader with the need to access a team of specialists in categories like medical monitoring, regulatory and statistical consultancy.
Regardless of the situation CROS NT, as a full-service CRO, is poised to ‘fill in the gaps’ no matter how large or small an organization, or regardless of its specific needs for extra assistance. This expertise is delivered by CRO personnel who have honed their skills and gained their knowledge from an exceptionally broad range of experience.
A Full-Service CRO Reduces Time & Costs & Improves Efficiencies
Reducing time and costs while ensuring safety and quality are key factors in choosing a CRO. Flexibility in delivery of those services is also a substantial factor. How the CRO expertise is harnessed for the best possible outcomes can take many forms. It may be beneficial for the Sponsor to adhere to an ad hoc consultancy agreement or block-book experts’ time for a few weeks or months.
Large pharma, for example, may need one company with a particularly good roster of experts in many different areas. This can ease outsourcing activities because all areas of expertise can be listed within one agreement.
As another example, biotech may simply need a virtual team extension. As such, it can be better for them to seek resources that can be called on repeatedly which naturally ensures knowledge retention and progress as they move through the complexities of the drug development process.
Just how the expertise is harnessed can take many forms. Should a Sponsor, for example, need specific assistance with CDISC compliance, CROS NT is able to step in to provide technologies that manage the flow of data with a central database to provide an easier mapping process. As a CDISC Gold Member, CROS NT has immediate access to new data standards and documentation. This position allows CROS NT to help pharma, biotech and medical device companies incorporate CDASH, SDTM and ADaM standards into their organizations and map legacy studies to create consistency in formats, which reduces time, costs and ensures consistency and quality assurance.
Accessible Expertise: Areas of Assistance
With the complexities inherent in developing competent and thorough clinical trials that adhere to the latest regulatory requirements, it’s important to partner with a CRO that offers not only proven expertise but also access within your time zone. CROS NT is able to deliver with a competent and knowledgeable team of resources in clinical, regulatory and biometrics in North America and Europe.
Sponsors should expect from their CRO a range of ‘accessible expertise’ in many areas, including:
- Study Design
- Regulatory Development Plans
- Regulatory Submission Support
- Data Management Support
- Statistical Consultancy
- CDISC Compliance
- Integrated Summaries
- Medical Writing
- Integrated Pharmacovigilance Service
All of these services, tailored, flexible and immediately accessible are wrapped into CROS NT company values including, trust, integrity, commitment, innovation, passion, communication – all of which inspire a commitment to quality clinical research results.