New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today’s landscape puts sponsors under more pressure than ever before. Clinical trials are becoming increasingly complex, regulatory bodies increasingly demanding, and stakeholders increasingly scrutinous.
Considering the resources invested in R&D, managing everyone involved internally and externally for years is akin to a trapeze act: maintain a strong focus and adhere to minute details, prevent incidents and accidents and keep the participants, observers and patrons satisfied.
To alleviate the workload, ensure the teams work in a unified manner, and keep a firm hold on procedures and timelines, organizations may find it more profitable to hire external resources for the duration of the trial or for specific projects. A clinical operations team will act as a liaison between all moving parts of the study, making sure communication is open and execution is on time.
Here are five scenarios that justify bringing in expert reinforcement.
Study Design and Management in Increasingly Complex Clinical Trials
Study design is one of the most important elements of successful product development. Sadly, promising drugs don’t make it to market because of major flaws from the start.
Clinical research is time sensitive and managing deadlines is one of the many challenges that investigators face. This is especially true in Phase I management, when site selection and recruitment are crucial factors of success.
Treximo has the clinical expertise to assist you from Phase I to IV. We provide benchmarking and analytics and can help you select sites, assess study feasibility, recruit patients, and access support throughout the duration of the trial.
Keeping a Tight Grip on Regulatory Requirements
In a heavily-regulated industry, reaching compliance in clinical research comes with its own suite of challenges. Different regulatory bodies publish different sets of guidelines and approval processes vary between countries. In the United States alone, pharmaceuticals experience the scrutiny of various federal agencies (FDA, OHRP, OIG, etc.) determined to enforce regulations and protect the public.
Under the FDA oversight and governance only, one single issue can derail a trial and let years of work go to waste. Common issues include:
- Informed consent execution
- Protocol deviations and violations
- Drug and device accountability
- Medical records maintenance
- IRB approval
Treximo’s teams will support you in your compliance program initiatives so your efforts to bring new drugs or devices to market meet success. Thanks to our consulting experience in the pharmaceutical, biotech, and medical devices industries, regulations are no longer a nightmare.
Balancing Tight Timelines and Budget Considerations
Developing a new drug comes with a hefty price tag. Once the clinical trial milestone is reached, time seems to accelerate. Tight timelines are the norm and any hiccup adds to the team’s workload. Study costs can quickly spiral out of control, which poses a threat to small organizations that operate with finite resources.
A study by Eastern Research Group, Inc. for the U.S. Department of Health and Human Services reports the following therapeutic areas bear the highest burden from Phase I to Phase IV:
- respiratory system ($115.3 million)
- pain and anesthesia ($105.4 million)
- oncology ($78.6 million)
Across all phases, key cost drivers are:
- Clinical procedures
- Administrative staff
- Site monitoring
- Site retention
In order to keep expenditures under control, study management, technical complexity, and trial paperwork must be kept in check. Often, in-house resources become insufficient to oversee all aspects of a trial.
Minimizing the Need for Protocol Amendments
Most protocol amendments are unavoidable. However, a study by Tufts Center for the Study of Drug Development highlights the impacts of amending protocols and points out that more than 1/3 of changes could be avoided with flawless protocol designs and optimized volunteer recruitment processes.
Treximo proposes strategies to improve trial efficiency and increase performance. Our clinical operations services leverage the availability of new technologies, help remodel organizational processes, and contribute to improved protocol design.
Liaising All Moving Parts of the Clinical Trial Team
From principal investigator to research coordinator, setting up a clinical trial takes a village. Each team member has a specific role and adheres to precise execution criteria. How well-oiled the machine is determines the success rate of each phase.
One benefit of hiring clinical operation outsiders is the ability to act as a liaison between all members, whether on-site or remotely. Ensuring smooth communication and timely information is one of the many hats a CRO wears to support organizations in their clinical and operational goals.
According to the Biotechnology Innovation Organization, the overall likelihood of approval (LOA) from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology. A success rate of less than 10% is not enough in today’s landscape. Too many diseases need attention and too many patients need better access to care.
If you wish to obtain approval to market a new drug or medical device but feel the burden of designing, managing, and implementing protocols while reaching optimal compliance, Treximo’s clinical operations teams have the solutions. From à la carte services to customized strategies, we’ve got you covered.
Get in touch for a no-obligation introduction to our services.