Choosing The Right CRO For Your Clinical Trials
In today’s interconnected world, it is almost impossible to find a business that doesn’t use vendors, contractors and consultants. There are very few vendors, however, that have a greater impact on the company’s bottom line than a contract research organization (CRO) has on biotech and Pharma (Sponsors). It is absolutely certain the CRO that you chose for your clinical program will become your company’s most important ally. Depending on Sponsor’s internal capabilities, its CRO partner may be asked to perform essentially every aspect of a clinical trial, from patient recruitment, clinical research services, regulatory support, to medical writing, biostatistics, data-management and pharmacovigilance.
A clinical trial is akin to a long sailing expedition and whomever you invite to sail along is unlikely to disembark midstream. Thus, you need to be unequivocally sure that you have chosen the right crew for your exciting, albeit challenging journey. A CRO that you bring in should share your vision, your values, your work ethics.
How to accomplish this undeniably challenging task? Here are some considerations that may help you make the right selection.
There is no universal checklist that one can refer to when choosing the “best CRO”, but there are certain criteria that aim to help a Sponsor in the process of selecting the “right CRO”. The most obvious but frequently overlooked items on your checklist should include the following:
- robust quality management system that ensures consistent high quality of performance that has been pressure tested by successfully passed audits and inspections;
- comprehensive and logical risk assessment and management system that allows to identify the most challenging aspects of the clinical program from the outset and that continuously and preemptively identifies the new threats throughout the lifecycle of the trial.
- therapeutic area expertise that allows the CRO to utilize its prior learnings for the benefit of your clinical trial;
- access to the right pool of patients and focus on patient-centric approach, that is, the CRO can demonstrate that it has access to the sites with high enrollment potential and with a track record of delivering high data quality;
- geographic reach that assures that your CRO can offer a wide selection of clinical trial venues both domestically and internationally;
- in-depth knowledge of local regulatory environments that ensures understanding of and compliance with all relevant local practices, laws and regulations;
- training and continuous education that shows CRO’s dedication to implementation and maintenance of a robust continuous professional education and quality improvement training programs for all staff members;
and last but not least:
- pricing. When evaluating a budget proposal be aware of unit costs and covered services. The least expensive proposal may eventually turn into most expensive one. Ask about the historical rate of change orders and drill down on potential hidden costs;
- availability of a risk-sharing program. Ask it the CRO offers a risk-sharing solution hat allows the Sponsor to pay for performance.
We have compiled a list of essential documents that can help manage the effectiveness of the anticipated sponsor/CRO collaboration
- Project Management Strategy
- Regulatory Strategy
- Risk Management Strategy
- Trial Master File (TMF) Strategy
- Monitoring Plan
- Communication Plan
- Goals and Milestones Timelines
- Budget and Contract Trackers
Inability of a CRO to provide these documents should become a reason for concern.
Call us subjective but we feel that when selecting a CRO partner Cromos Pharma should be on your radar. Here is why.
Expertise and years in business
- Over the past 18 years, Cromos Pharma has conducted over 300 clinical trials across a wide range of therapeutic indications and has substantive experience in managing its every aspect.
- Cromos Pharma’s team has almost two decades of experience in regulatory submissions for innovative biotherapeutics, cell therapies, antibody-drug conjugates, immuno-oncology, as well as in complex generics, biosimilars, and other follow-on drugs.
Quality Management System (QMS)
- Cromos Pharma’s Quality Management System is built upon Quality by Design principles that include integrated planning, quality agreements tailored to each project, real-time project risk-based analysis, data analytics-driven targeted monitoring, and customer-focused project optimization, all aimed to deliver the highest quality of clinical trial data.
- Cromos Pharma’s certified auditors perform a wide range of internal audits that cover all key quality processes that helps us continuously improve our services.
- Cromos Pharma offers intensive training programs based on personal training plans supported by the company’s intuitive electronic Learning Management System.
Access to the Right Pool of Patients, Recruitment and Focus on a Patient-Centric Approach resulting in High Retention Rates
- Cromos Pharma’s carefully selects the right sites and works with them to maximize the enrollment potential. Effective pre-screening strategies to identify suitable patients have resulted in an unparalleled track record of patient recruitment, allowing it to meet or shorten project timelines in 95% of conducted trials.
- Cromos Pharma is fully compliant with ICH-GCP and ensures that the patients are well-informed and have a direct line of communication with the investigators and research team.
- Direct-to-consumer outreach, robust reimbursement procedures for enrolled patients, and priority in protecting the health and safety of the trial participants ensure effective launch and subsequent conduct of every clinical
- Cromos Pharma’s geographic strategy is designed to accommodate global requirements by offering the highest enrolling venues across the US, Central and Eastern Europe, Central Asia and Türkiye, while making sure that all selected sites have comparable medical standards of care.
In-Depth Knowledge of Local Regulatory Environments
- Operating in accordance with the relevant FDA and EMA Directives, Cromos Pharma has local regulatory knowledge, experience, and skills that provide an invaluable asset for the Sponsors wishing to conduct clinical research in a variety of jurisdictions.
- Cromos Pharma’s team has deep knowledge of national legislation and experience in working with regulatory agencies (RA) and ethics committees (EC) in multiple jurisdictions including the US, Central and Eastern Europe, Central Asia and Türkiye.
- Cromos Pharma offers a European Union Legal Representative service to Sponsors who do not have a registered office in the EU/EEA, saving Sponsor’s costs and resources.
“No Patients – No Payment”
- Cromos Pharma’s unbeatable recruitment is supported by its unique proprietary “No Patients – No Payment” risk sharing program that assures that your enrolment goals, budgets, and timelines will be met.
We hope that this short overview has added to your understanding of how to choose the “right CRO”. If you want to learn more about CROs and how to effectively collaborate with them, please visit the “Expertise” section of our website or get in touch with us by emailing firstname.lastname@example.org.