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5 Things to Look for In an Early Phase CRO to Make the Most of Your Partnership
5 Things to Look for In an Early Phase CRO to Make the Most of Your Partnership
Finding the right contract research organization for your company’s early phase drug development program can be challenging. Do you choose to partner with multiple subcontractors or a full-service CRO for preclinical, manufacturing, bioanalysis, and early phase clinical development? Making these decisions and choosing the right CRO for your first in human clinical trials can help streamline your study from the start.

One of the most vital steps of early clinical development is choosing which contract research organization you will partner with. Selecting the right CRO is an essential aspect of your drug development program, especially since it can affect critical decision-making. The CRO you choose should share your vision, understand your goals, and offer flexible, integrated services to support your organization along the way. Here are some important things to consider when choosing your organization’s CRO partner.

In Some Cases, the Size of the CRO Can Determine Flexibility

Would your organization benefit more from a large CRO or a smaller one? With a bigger CRO, you might have access to more resources, but a smaller CRO might be able to offer more personal contact and allow your organization to provide more input in the process. Or a mid-size CRO could be more flexible and able to adapt their processes to match your needs. No matter your preference, be sure to partner with a CRO that emphasizes responsiveness and the relationship with your organization.

Integrated Processes and Services Can Streamline Outsourcing

Early phase drug development is a complex process where many moving parts can influence the success of a program. Moving your program from one partner to another as it achieves new milestones can be inefficient. In many cases, you have to re-explain your data, processes, protocols, preferences, and drug requirements to each new partner. With a single, full-service CRO, you can create clear communication and seamless coordination. Imagine if you could select a single integrated CRO / CDMO that could take your drug from lead candidate selection to first in human clinical trials, proof of concept and beyond, including drug manufacturing, bioanalysis and CRO services. By taking advantage of an integrated process and striving for improved communication, you can enjoy a streamlined drug development program.

Experience Helps You Avoid Potential Obstacles

Whether it’s niche expertise or regulatory knowledge, the staff of the CRO you decide to partner with should have the experience you need. Combine an innovative approach to clinical development with decades of scientific and operational experience, and you have a great candidate for a CRO partner. Your CRO of choice should be able to help guide you through your drug development process with help from scientists, technical staff, management, and professionals with varied backgrounds in pharmacology and biotechnology.

Resources Available Through the CRO

What resources does the CRO have access to? Will they have to use a subcontractor, or do they have access to all the necessary resources and expertise for your project, such as Phase 1 clinical trial units? Do they have enough beds for your study? Do they have the right equipment and training to use the necessary equipment? If they need to use subcontractors, do they have a curated list of preferred vendors that have been qualified by thorough audits? With a full-service CRO, you won’t have to worry about finding the right vendors and sharing information with each of them.

Proven Results Inspire Confidence

When it comes to proven results, there are some essential questions to ask. Has the CRO demonstrated successful audits performed by regulatory agencies? Has it made verifiable contributions to drug development programs in the past? Is the CRO known in the industry for data integrity? A reputation for developing realistic timelines that are consistently met is another good indicator of a reliable CRO. Awards and recommendations from other companies in the industry can also increase your confidence in partnering with the CRO.

About Altasciences

As a mid-size CRO/CDMO, Altasciences offers pharmaceutical and biotechnology companies a proven, flexible, full-service approach to preclinical and clinical pharmacology studies. These studies include program management, medical writing, biostatistics, clinical monitoring, data management, formulation, manufacturing, and analytical services, all customizable to specific sponsor requirements. Altasciences has been partnering with sponsors for more than 25 years to help partners make educated, faster, and more complete early drug development decisions. Altasciences provides access to essential resources for early clinical development, including strategically located Phase 1 clinical trial units, access to over 580 beds across the U.S. and Canada, and over 1,000 trained staff members. Altasciences’s expertise covers a wide range of therapeutic areas, and the CRO is recognized as a leader in the field of CNS clinical trials.

Partner with Altasciences for your organization’s drug development study at https://www.altasciences.com/

Original Source: https://bit.ly/3c2wdCp