When it comes to pre-clinical and clinical research in drug and therapy development, there are several areas of responsibility where sponsors may outsource key functions to a Contract Research Organization (CRO). The reasons vary, but the top two are cost effectiveness and targeted expertise. The landscape of the drug development process continues to change and challenge how resources are allocated. CROs have existing framework to take on responsibilities without the sponsor having to invest in the infrastructure, equipment, and personnel required to move the extensive development process forward.
Today there is tremendous flexibility in the drug development process due to the partnerships between sponsors and CROs. This is evident by the number of companies offering CRO services. According to IBISWorld, a trusted provider of industry research, in the United States alone there over 4,000 CROs in a $20.9 billion market.1,2 Success relies on partnering with the right CRO. While service cost is important, it is not the primary consideration for most successful CRO partnerships. Here are Microbiologics’ top 5 success strategies for picking the right CRO partner.
1. Ensure niche expertise
A CRO is an extension of the sponsor and thus, must not only offer the services required, but offer expertise to help in the development process. A trusted CRO will have scientific expertise similar to the project in question, seasoned project management support, and a proven track record. Ideally, the CRO will offer all of the requested services under one umbrella. It is a good idea to ask about their outsourcing policies and if any of the required work will be performed elsewhere. A successful partnership starts with conversations, and in this case, probably several. Interview the CRO to get a feel for their knowledge and comfort level with the project. An experienced CRO will have representatives from cross functional departments (i.e., Scientists, QA, Project Managers, and Operations personnel) available during these initial meetings. This lays the groundwork for transparency and robust communication of expectations and timelines.
2. Confirm there is an established Quality System
Pre-clinical research is conducted according to Good Laboratory Practices (GLP) and regulated by the FDA under 21 CFR Part 58.3 Good Clinical Practice and Clinical Trials (GCP) are made up of several FDA 21 CFR regulations and are not in one, consolidated chapter.
To further cloud the issue, a CRO is often asked to be compliant with Good Clinical Laboratory Practices or be GCLP compliant. GCLPs are a combination of GLPs and GCPs. Simply put, GLP is a quality system aimed at ensuring the generation of valid, high quality laboratory data. GCP is a standard promoting the ethical and scientific quality of a study involving human participants. Therefore, the marriage of GLP and GCP ensures a study is conducted ethically and safely while producing trustworthy data that is consistent, reproducible, and maintained with data integrity.
The CRO should have a Quality System that documents processes, procedures, and responsibilities for meeting customer and regulatory requirements. Examine the CRO’s quality system. If there is no certifying body where specific quality elements are required (e.g., ISO), then ask specifics as to how they assure quality for their customers. Controlled processes for sample chain of custody and sample handling are critical for preventing mix-ups with other studies or projects. Also, procedures for data preservation and integrity are required and should be included in their quality system.
Because a CRO takes on a targeted area of responsibility on the sponsor’s behalf, it is important that they have quality procedures pertaining to the specific areas of interest. It may not be reasonable for them to be compliant with all the regulations that govern clinical trials. The sponsor should audit the CRO and look for objective evidence of compliance with their quality system and regulations needed to support the project. Keep in mind that a formal quality system does not guarantee compliance and cannot replace an audit. Since the CRO is an extension of the sponsor, the sponsor is responsible for all actions of the CRO they partner with. Auditing the quality system will provide insight into both capabilities and gaps.
3. Establish data sharing expectations
Decisions are based on timely, high quality data at all project stages. Paper based processes can be cumbersome and inefficient. Utilizing technology provides solutions for data handling and management, but comes with other, unique challenges that encompasses the entire data lifecycle (data capture, analyzation, interpretation, and retention). How the CRO will organize and share data is important. Begin by asking some probing questions, such as: How does the CRO maintain confidentiality of participants and of the data generated? Is there a system in place for electronic data capture or a laboratory information management system for analyzing results? Are these systems compliant with 21 CFR Part 11 for electronic records and signatures?4 Are there policies for data security and data integrity? If the project will span several months, how often should results be provided and in what format? Is encryption of communications required or will there be a secured site or server where the information will be uploaded? Other data handling considerations may include how deviations or incident reports are handled and shared. Should these be communicated on an “as occurring” basis or summarized in the final report? Setting data sharing expectations is a critical step in a successful CRO partnership.
4. Opt for flexibility
Potential CROs should be interviewed similar to job candidates. If you have narrowed your decision to 2 or more potential partners, ask additional questions to get a feel for how flexible the CROs are. Clinical research is a bumpy road that requires expert navigators and flexible participants. Project hurdles, shifts in focus, changing priorities, and problems are inevitable. Working through these expected challenges requires a CRO to shift gears smoothly without adding undue delays. Ensure there are sufficient resources (facility and personnel) to execute the project and overcome the unexpected. Additionally, you want to make sure you are treated as a priority and get the attention you deserve even if you have a relatively small project.
5. Have an escalation process for a robust oversight plan
CRO oversight is a critical responsibility of the sponsor. Regular meetings can keep things on track and ensure that the CRO is doing what is being asked, following the plan, and meeting overall expectations. Important gaps can occur when there is not a defined escalation process. Having an escalation process for communicating and resolving issues will help enhance the oversight of bumps in the road that impact contract deliverables, CRO critical staffing, expected outcomes, and timelines. The types of issues requiring escalation will vary depending on risk and the project. The escalation process should be deployed when critical issues arise that require awareness, input, or resolution from both the sponsor and CRO. Establish upfront what would require escalation so there are no surprises. Communicate what will be in the oversight plan, including what requires immediate escalation versus what can wait until the next routine, scheduled meeting.
Trusted Partners in Virology
The Microbiologics, Inc. Global Virology Center offers customized support for the development and validation of assays, vaccines, and therapies. In addition to viral stock propagation, reverse genetics, and consulting services, we offer in-vitro viral testing and assay development for research, pre-clinical, and clinical trial testing. Our scientists and site leaders are part of the development and collaboration process from the beginning, ensuring expectations are clearly defined. We are ISO 13485 certified with an established QMS and comply with GLP regulations. Contact your Microbiologics, Inc. partner to learn more about a CRO partnership.
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- Contract Research Organizations in the US – Number of Businesses. (28 November 2020). Retrieved from https://www.ibisworld.com/industry-statistics/number-of-businesses/contract-research-organizations-united-states/#:~:text=There%20are%204%2C087%20Contract%20Research,increase%20of%203.4%25%20from%202020
- Contract Research Organizations in the US – Market Size. (28 November 2020). Retrieved from https://www.ibisworld.com/industry-statistics/market-size/contract-research-organizations-united-states/
- Electronic Code of Federal Regulations. Retrieved from https://www.ecfr.gov/cgi-bin/text-idx?SID=b04bc1d8d27614a55a09d906af3ad786&mc=true&tpl=/ecfrbrowse/Title21/21cfr58_main_02.tpl
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials. Retrieved from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials