Biopharmaceutical companies seek the help of contract research organizations (CROs) to help them navigate the intricate terrain of drug development and regulatory pathways to introduce innovative treatments into the market. A Biotech startup should inquire about 10 crucial aspects before selecting a CRO.
The selection process, based on factors such as expertise, location coverage and capability to achieve sponsors’ clinical objectives is crucial for biotech start-ups or emerging entities that are aware their needs differ from others.
Here are some inquiries you should consider when choosing a CRO:
Which Services Related to the Trial are Necessary?
During drug development, biotech start-ups may require the help of CROs to access expertise in clinical trial management and therapy experience that they have not yet developed within their own company.
The crucial factor at this point is determining what duties are necessary for the trials and which unique supportive services will be required.
More than just having adequate capabilities, it’s important for small biopharma firms to find a compatible CRO with similar values and corporate culture.
What are the CRO’s Capabilities and Experience?
Competencies: Having compiled a list of potential Contract Research Organizations (CROs) that can meet your requirements, inquire whether they possess pertinent expertise in conducting comparable studies – encompassing aspects such as design, location and therapeutic domain – and if they have efficaciously incorporated technology to enhance clinical trial efficacy.
Some CROs like Eclevar specialize extensively in certain maladies or regions and are also primed to assimilate innovative tools, pinpoint prospects for their application, and furnish feedback on the feasibility of deploying them.
Is there a Quality Assurance process in place for the CRO?
Quality Assurance and Compliance: Confirm that the potential CRO possesses a management system for quality assurance, which adheres to regulations and guarantees their ability to deliver promised services with respect to meeting your clinical objectives.
Is the Communication of the CRO effective?
When it comes to communication, make sure that both you and the CRO are aligned in terms of expectations. This includes determining how frequently and through what means the CRO will communicate with your internal teams.
Ensure that the CRO promptly shares any unexpected challenges or alterations so that you can work together towards solutions. For complicated clinical trials, sponsors require a knowledgeable team from their chosen CRO which pays attention to even minor details.
Any modifications within this team may result in prolonged timelines and disturbances at research locations. Smaller contract research organizations typically have lower staff turnover rates than larger ones – giving greater stability and consistency for those overseeing these critical projects.
How does the CRO tackle difficulties that arise during a trial?
To navigate the potential obstacles that may arise during clinical trials, sponsors require CROs with a transparent and adaptable approach, as well as effective problem-solving abilities.
Customization is key in this process, which can be facilitated by smaller CROs who are better able to propose new solutions and execute them alongside their clients.
For first-time drug developers within small biopharma companies seeking specialized expertise that addresses regulatory hurdles on both tactical and strategic levels for targeted therapeutic areas, Eclevar provides an ideal solution.
What is the feedback of clients regarding CRO?
When assessing potential CROs, it’s important to inquire about their track record for client satisfaction and success. This can be achieved by requesting performance metrics such as meeting deadlines within budget constraints or policy on change orders if cost certainty is a priority.
For optimal client satisfaction, small CROs provide personalized service with frequent interaction and thorough supervision. Small CRO partners are attentive to the evolving needs of emerging biopharma clients while being responsive in a collaborative model akin to that between equals.
Is there a plan for the CRO to adopt outsourcing and, if so, how will they ensure that service quality is maintained?
Assess the CRO’s decision on whether to outsource or subcontract certain aspects of the clinical trial operations. Also, examine their approach towards ensuring that they deliver what was promised about quality service and meeting your specific clinical objectives.
Eclevar is deeply dedicated to fulfilling its goals of running top-notch trials with swift execution. Thus, significant investments have been made into building exclusive technology products and services such as Eclevar – a tech-enabled system designed for enhancing performance during trials.
How does the CRO interact with patients?
Digital health technologies have transformed clinical trials from being focused on the site to prioritizing patients, in an effort to decrease patient burden and enhance treatment adherence. This shift promotes engagement among patients while simultaneously achieving higher-quality data collection at a faster pace.
Eclevar is a Contract Research Organization (CRO) that recognizes this potential for improving trial outcomes by creating technology designed specifically for patient-centric studies such as electronic Patient-Reported Outcome (ePRO).
The Eclevar ePRO delivers a personalized experience compliant with regulations specific to participants within clinical trials – offering participant-directed reporting of their individual health status through digital questionnaires or diaries via computerized devices.
In what way will the trial development incorporate feedback from patients?
How does the CRO assess trial eligibility requirements while setting achievable recruitment and retention goals? Evaluate whether the potential CRO has a strategy to conduct patient research and engagement activities for gaining valuable insights into the target population of participants.
In case your study requires it, ascertain if they possess prior experience in adaptive trial design methodology aimed at enrolling patients who are likely to receive maximum benefits from treatment interventions.
Has the CRO conducted trials internationally?
If you plan to conduct a clinical trial in several countries and regions, look for a CRO that has expertise in managing trials within your chosen locations. Regulations concerning clinical research differ locally, and an experienced CRO can assist with overcoming obstacles to ensure successful completion of the study.
To learn more about the clinical research industry and beyond, follow Eclevar on LinkedIn.
