Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market.
Lasting partnerships between CROs and pharmaceutical companies are vital to the long-term success of ongoing programs and clinical trials. When a CRO fails to meet certain criteria relating to safety protocols or deadlines it can leave some companies questioning whether or not they should switch CROs to mitigate risk, manage budgetary bloat, and more importantly, salvage an ongoing clinical trial or program.
CROs provide these services, but are not limited to…
- Biopharmaceutical development
- Bioassay development
- Clinical trials
- Preclinical research
- Quality and metric reporting
- Sample and data management
Bringing a drug to market doesn’t just take a great deal of funding, but years of research and energy-intensive testing. With the cost of conducting clinical trials rising each year, it is easy to see why hiring a competent and experienced CRO at the onset of your project is so important.
According to the National Institutes of Health (NIH), the rapidly rising costs of clinical trials has been worrying researchers for decades, stating, “The cost of conducting a clinical trial for a drug is rising like mercury on a summer afternoon, a trend that researchers say is hampering the development of new medicines and is bad news for academia, pharmaceutical companies and consumers.”
Hiring a CRO with a proven track record of success in bringing clinical trials to fruition is vital to the success of your project, so choose wisely. Accuracy of data, safety and meeting timelines are all important factors. When one of these elements is impacted or compromised it can cost a great deal of money and maneuvering to correct course.
The Benefits of Hiring the Right CRO
If you are a pharmaceutical company without a competent CRO on your side, it could mean considerable delays in bringing a drug to market, which in turn costs money. The implications of not hiring the right CRO could lead to financial strain for sponsors, while also negatively impacting patients if the project isn’t responsibly executed.
Hiring the right CRO will ensure your trial meets timelines and maintains quality standards. Here are some factors to consider when hiring a contract research organization to ensure you’ve selected the best company to meet your project goals.
- Save on labor and resources: Some pharmaceutical and healthcare organizations may lack the experience, equipment and labor force to successfully see a clinical trial through to fruition. Joining forces with an experienced CRO can save companies a great deal of time, effort and money that it takes to overcome these hurdles. Another perk of partnering with a CRO is being able to take advantage of their expertise. Most professional CROs will have access to the most cutting-edge diagnostic equipment, while also being knowledgeable about the most effective methods for getting accurate results.
- You’ll most likely save time: Regulatory obstacles and legal requirements can consume a considerable amount of time and may put your project in jeopardy of not meeting important timelines and milestones. CROs are pros at navigating the complicated waters of various regulatory bodies, and experts in ensuring that clinical trials get approved. After all, this is one of their central roles. Aligning your company or institution with the right CRO could save you time, and in some cases, may help speed up the clinical trial process.
Considerations Before Switching CROs
Changing CROs mid-project or mid-program can be a risky proposition. On the other hand, not switching CROs may present a greater risk to your project depending on a number of factors. Here are a few things you may want to consider before handing your clinical trial off to a more capable and experienced CRO.
- Contractual Complications – Make sure you fully understand the costs associated with terminating your contract. In some instances, if your current CRO has proven to be solely responsible for a clinical trial being delayed or prematurely coming to an end, you may be within your rights to switch CROs and avoid substantial financial penalties.
- Time Loss & Past Rescue Rate – If you are considering switching CROs in the middle of a project or clinical trial it is vital that you choose a CRO that has past success in taking on projects midway through. Be sure to ask prospective CROs what their rescue rate is as it pertains to past projects and how they have managed a transition without disrupting project timelines or impacting the integrity of a clinical trial.
Are You Switching CROs? Contact BioAgilytix
Do you have a complex large molecule project that has hit seemingly insurmountable scientific roadblocks? If you are thinking about switching CROs, BioAgilytix is the clear choice. Bioagilytix is the most capable and qualified large molecule bioanalysis lab in operation right now with a 100% rescue rate and has been highly successful at taking on projects that previously timed-out on someone else’s watch.
BioAgilytix invests more time upfront in regards to development. This ensures a successful outcome while also adhering to tight and reliable timelines. This helps sponsors avoid costly issues like those described above.
Our team of bioanalytical experts has a spotless 10-year regulatory track record. We are always prepared to rescue the most challenging large molecule studies. Tell us more about your needs and we’ll provide our recommendations on how to get your project back on track, quickly and effectively. Contact BioAgilytix today for more information on our wide range of bioanalytical services.