BlueClinical

Taking time out to ensure that one has a backup plan is always a good idea. However, while organizations may have designed fail-safes to secure their bottom line from numerous threats, they failed to consider a pandemic. And these companies ironically include the ones operating in the fields of biopharmaceuticals and clinical research as well. The COVID-19 pandemic caught the world off-guard and the strict lockdown protocols that followed gave rise to a lot of problems for contract research organizations (CRO) to even begin conducting early-stage clinical studies towards developing a vaccine. But BlueClinical, a CRO established for the purpose of being an active component of early phase clinical development, had a contingency in place for just such a situation that 2020 has so unexpectedly brought forth. “The current major challenge for organizations is to implement studies under the context of COVID-19, and we have several emergency measures in place to continue conducting clinical studies in a safe environment, both for participants and clinical staff,” expresses Dr. Luis Almeida, MD, PhD, and founder and managing director/CEO of BlueClinical. Alongside the general safety guidelines like social distancing and symptoms monitoring, the company also quickly set up screening and ambulatory areas for teams that dealt with inpatient volunteers while issuing robust equipment sanitization procedures as well.

With such immaculate safety nets in its INFARMED and US FDA-inspected, 86-bed clinical pharmacology unit, BlueClinical is able to successfully deliver comprehensive assistance in bioequivalence and Phase I clinical studies regardless of an ongoing pandemic.

“We are specifically dedicated to conducting phase I studies, among healthy volunteers and selected patient populations.BlueClinical is highly capable and executes diverse types of studies all the while satisfying the strictest regulatory requirements,” states Dr. Almeida. The company offers first-in-human (FIH) single and multiple-dose escalation, PoC, bioavailability/ bioequivalence, and drug-drug interaction studies, among many other services. And to ensure a seamless experience for clients during the planning stages of a study or trial, Dr. Almeida and his teams take an extremely flexible approach to the projects they encounter. “We are willing to discuss any designs that sponsors may be considering for their studies,” he adds.

BlueClinical maintains a database of more than 8500 healthy volunteers alongside a highly-qualified team of over 120 employees that includes doctors, who specialize in various disciplines. Leveraging the collective experience of such a strong workforce, the company supports researchers by improving their adherence to the many international regulations while delivering a full-fledged product.

The company provides services that include the BlueClinical Phase I operations as well as R&D consultancy services. The CRO’s effectiveness in driving results for clients lies in its ability to streamline a product’s commercialization cost-effectively, which makes all the difference in an increasingly competitive marketplace. “Time-to-market is extremely important for sponsors and can influence a project’s success,” says Dr. Almeida. He strongly believes that BlueClinical’s success is highly correlated to a client’s project’s success, and so his staff strives to optimize timelines of clinical operations, aiming to lower a new drug’s time-to-market.

With such an extensive portfolio of services, BlueClinical is one among the few CROs today that thoroughly understands the need of the hour and follows through. Moving forward, the company intends to perform more complex studies with innovative molecules and complex dosage forms while expanding its capabilities for studies in healthy subjects.