A CRO is a Contract Research Organization. CROs provide sponsors (pharmaceutical, biotech and medical device companies) with research management services. Traditional CROs provide clinical trial management services, while laboratory CROs provide drug discovery, manufacturing, laboratory and bioanalytical services. Typically, sponsors outsource these services to save resources on the development of their new drugs.
In the late 1970s and early 1980s when CROs were first formed, they specialized in a particular service, such as data management and statistical services, regulatory support or clinical research monitoring. Today, most CROs are full-service, providing complete clinical trial management support.
What do clinical trial management services include?
Clinical trial management services typically begin with assisting the sponsor with clinical study design. This can range from creating the full protocol to providing a review and comments on the sponsor’s draft protocol.
Clinical trial management services also include site feasibility. This is when the CRO is responsible for finding the clinical research sites to participate in the trial. Depending on which phase of the trial, this service can be time consuming. Searching for sites with relevant experience and reaching out to those sites to collect their interest resource availability requires extensive follow up and tracking.
Project management is one of the main service areas of a CRO. The project management service ensures project execution is progressing as intended, assessing project metrics and timelines, implementing corrective actions (if needed), tracking study budgets, managing third party vendors and developing the overall trusted partnership with the sponsor.
Monitoring services play a critical role in clinical trials. The CRAs (clinical research associates) or trial monitors are the main contact for the sites. CRAs communicate with the sites frequently to review project timelines, expectations, discuss study updates, AEs/SAEs (adverse events/serious adverse events), assist with study supply needs and provide overall support to ensure the sites feel their participation is important. The CRAs travel to the sites to ensure protocol compliance is met and review data for any discrepancies.
A CRO may be contracted to provide medical monitoring services. Medical monitoring services ensure patient safety in a clinical trial. Review of adverse events, concomitant medications, safety data as well as providing 24/7 availability to project teams and sites for safety questions are all part of medical monitoring services.
Biometrics services provide the sponsor with the data, analysis and reports from the clinical study. Services can include creating the data collection forms and programming the software to capture the data, ensuring the data is entered into the system properly, conducting the statistical programming and analysis as well as writing the final clinical study report for the sponsor.
CROs offer organizations a chance to meet with experts and professionals in a particular field and have an in-depth conversation about the best processes to use, potential issues to be concerned with, and the optimal solutions for overcoming them while conducting their clinical trials.
Understanding the strengths and limitations of internal and external resources can help organizations in the medical field adapt when unforeseen problems arise. CROs are able to help ensure processes are efficient, well-organized and maintained.
Frequently, organizations in the medical field lack the resources necessary to keep their staff updated on the best practices and methodologies in research. A CRO empowers healthcare professionals by giving them access to tools and knowledge that they may not have in-house, and would have otherwise been unable to deploy.
By outsourcing to a CRO, organizations can ensure their staff is trained to conduct comprehensive research. CROs provide instruction to organizations to ensure their information is trusted, reliable, and relevant.
Tracking Progress and Metrics
For most organizations in the medical field, keeping projects on track is crucial. The risks of losing out on important data due to fatal mistakes can leave them low on resources and meeting critical endpoints.
CROs help teams across the organization track and process data so that research objectives can be met with precision. By providing measurable data, CROs help research organizations remove uncertainty in error detection and baseline metrics tracking throughout the project.
What Is a CRO Able to Do for Professional Quality Assurance?
Professional quality assurance provides organizations with a means to ensure their clinical research and practices are followed by the FDA regulations. CROs provide quality analysis, regulatory planning, and safety training.
Quality assurance relies on understanding which processes are effective and which are wasting resources. The development of ongoing processes to define and track problems within medical research is difficult and leaves organizations with less time to complete their projects.
CROs adopt standardized operating procedures (SOPs) and help train organizations that they work with to do the same. The development of methodologies that allow research audits to take place throughout the clinical trial process saves time and resources.
Regulatory hurdles and legal frameworks can make it difficult for clinical trials to take place. Organizations doing clinical trials have to be careful not to break the laws of their country.
CROs offer a way for medical organizations to ensure they comply with local governance requirements. Understanding legal regulations ensures research won’t be stopped midway through by a misunderstanding of the law.
Vial Provides the Tools to Execute High-Quality Projects
We work closely with our partners to provide strategic execution of their visions, ensuring smooth operations while mitigating key risk factors.
Vial provides site locations where studies can be carried out, finds participants, and provides compensation for their time. We’ve fulfilled over 750 trials for more than 25 partners. Our professional networks of clinics, doctors, and nurses are here to help you complete your research goals.
About Vial: Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.