Altasciences

It’s nearly time to start early clinical development , and your organization is looking for a contract research organization partner. If you are looking for a fully integrated, all-in-one organization, there are some factors to consider. There are advantages to choosing a full-service CRO instead of partnering with multiple CROs, but a single CRO needs to be able to do everything proficiently. Here are four factors to consider. Do They Have All the Necessary Resources? When a CRO specializes in one discipline, they will likely have the necessary resources to perform that service extremely well. A CRO that can take you from lead candidate selection to clinical proof of concept to commercial manufacturing requires far more resources. The CRO needs the correct medical equipment for first-in-human clinical trials, that are run in their Phase 1 clinical trial units . Ideally, they would have a substantial database of clinical trial participants for recruiting for the study. This can make

In 2017, the FDA declared that driving simulation studies are required for all drugs that may affect cognition. During early clinical development , your organization must determine whether a driving simulation test is needed for regulatory approval. If so, it’s a good idea to partner with a contract research organization that has the experience and resources necessary to carry out the testing. Here are four reasons you should consider partnering with a CRO to conduct driving simulation tests. Recruiting Database Speeds Up Recruiting An experienced CRO will have access to an extensive database of potential participants for your study, from healthy normal volunteers to patients and special populations. These potential participants may have the necessary qualifications for your study or will be easier to screen than if you simply marketed the study to the general population. The CRO can perform the screening process, helping the study get started as early as possible. A recruiting datab

Whether you are starting early clinical development or considering Phase 1 clinical trials, you will likely want to partner with a contract research organization or contract development and manufacturing organization. Here are some key factors to look for, whether you are outsourcing a specific aspect of your ophthalmic drug development program or partnering with an integrated CRO/DCMO for the entire program.  Preclinical Safety Testing First and most importantly, search for a CRO/CDMO with plenty of experience. It’s best to find an organization that has never had a study rejected due to design, conduct, or data integrity. If the CRO/CDMO has had a study rejected, find out why. The organization should have a broad range of solutions across dosing routes, as well as the ability to use special techniques if needed. Specialized equipment for ophthalmic studies is definitely an advantage. Clinical Research Services and Resources If you are creating an ophthalmic drug and

Efficiency plays a key role when conducting clinical trials. As your company develops new pharmaceuticals, you want to move from one stage to another as smoothly as possible. When collecting data in early clinical development and preparing for manufacturing, there are many variables to consider. One of those variables is your drug delivery method during clinical trials. This detail can be overlooked in terms of variability but is essential when you want to collect high-quality data. If you’re developing a poorly soluble drug or supplement, the system of delivery makes a difference. Using tablets can produce different results when compared to liquid-filled capsules. You may even reduce the efficiency of your clinical trial by choosing one delivery method over another. Does this mean you should use liquid-filled capsules over other options? Here are some factors to consider. The Clear Benefits of Liquid-Filled Capsules When you work with a contract development and manufacturing organi

If your organization is looking for ways to save time and money by partnering with a CRO for your next drug development project, find an integrated CRO/CDMO. Typically, an integrated CRO/CDMO can help you with lead candidate decisions, safety assessment, early clinical development , and potentially even through the manufacturing process. As a result, this partnership can help streamline otherwise complex development processes. Here are some reasons you might want to choose an integrated CRO/CDMO partner for your drug development. Fewer Hand-Offs When you partner with the same CRO/CDMO from lead candidate selection through to first in human trials, there are fewer hand-offs and fewer partners to bring up to speed. When the CRO/CDMO team knows that you will need to do CNS clinical trials early on, it is much easier to account for all the necessary details and plan for subsequent steps in your study. Having a dedicated, cross-functional team to support you means easier scheduling, makin

What comes next after your drug discovery and safety assessment phase is nearly complete and you have secured funding? What are the relationships your company needs to build to continue your drug development program? What do you need to get into first in human clinical trials successfully? From partnering with a contract research organization (CRO) to helping your company conduct preclinical studies and clinical trials to discussing the intellectual property with a patent attorney, here are some tips for moving your drug to the next phase. When to Contact a CRO Regulatory processes and clinical studies have become more complex in recent years. Specialized knowledge is needed for smooth drug development. In-house experts can be expensive. Instead, many pharmaceutical companies are outsourcing to CROs, and biotech start-ups may rely on CROs to perform up to 90% of their tasks. Before starting your preclinical program or initiating clinical trials, consult with a CRO to develop a custo

You’re ready to enter early clinical development. All you need now is to find a clinical research organization that can handle the project you have in mind. However, finding the right contract research organization to meet your needs be a challenge. It comes down to matching your requirements with the capabilities and areas of expertise of the CRO. As you prepare for early clinical development , here are four things to look for in a CRO before you make the commitment.  A CRO That Keeps Things Simple You want to work with a CRO that provides a comprehensive experience. Much like an all-inclusive resort, you want all the crucial aspects of your partnership catered to in one place. In other words, you want to work with a full-service CRO/CDMO. This keeps the process streamlined and avoids the coordination required to work with multiple subcontractors at once or in sequence. Timelines are coordinated, communication can flow easily avoiding repetition and data is gathered and

When performing a clinical trial with a Schedule I, or Class I therapeutic, there are many aspects of the process to consider. Because these therapeutics require rigorous testing, your organization must ensure it is partnering with a CRO/CDMO that has the correct licenses in place, established shipping processes, customized testing sites, experienced scientific and technical staff, and much more. There has been an increase in CNS clinical trials focused on psychedelics, hallucinogens, and entactogens which have demonstrated potential therapeutic effects and deserve further research. If your organization intends to study Schedule I therapeutics in a preclinical, clinical, manufacturing or bioanalytical setting, you should be aware of the following potential challenges and considerations. DEA License for the Testing Site Before early clinical development can even begin, the CRO you partner with should have appropriate licenses from the Drug Enforcement Agency. The proper

Finding a contract research organization that has all the resources and processes in place to perform your clinical trials can be a challenge. Early clinical development , especially during a Phase 1 clinical trial, can set the pace, standards, and trajectory for the rest of your drug development program. Therefore, it is crucial that you make sure your CRO has access to all essential resources, processes and employs robust quality standards. Here are some tips to effectively identify and partner with a contract research organization.   Make Sure Your CRO Has Access to the Right Equipment When selecting a CRO to partner with, you need to investigate whether your chosen CRO have safe and fully equipped Phase 1 clinical trial units to perform every test on-site. This could include equipment for MRIs, biopsies, x-rays, telemetry, ultrasounds, and other assessment or tests. A simple discussion of the clinical protocol and study endpoints with your CRO can ensure your trial runs smoothly