Early Development Services: Accelerating the Clinical Process

Early development services are crucial to determine the impact and safety of a drug, and to spot potential signals of efficacy.

During the drug development process, companies have a choice of different approaches based on their development plan requirements. In order to access patients as early as possible, some integrate a drug-to-drug interaction (DDI), food effect or patient arm with a single ascending dose/multiple ascending dose (SAD/MAD) study, potentially providing early signals of efficacy in the patient population.

Others conduct multiple, simpler studies, sometimes in parallel and sometimes staggered, often reflecting the level of risk and complexity the sponsor is willing to incorporate into their drug program. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.

Benefits of early drug development services

Early development studies include many elements that set them apart from those in later development. Some of those include:

• Subject/patient population
• Rapid turnaround from study startup to top-line results or clinical study report
• Volume of Phase I studies

Unleashing the advantages of early drug development and clinical trials

An ideal early development partner brings teams that are:

• Experts in clinical program and trial design, able to recommend options for clinical development planning to meet multiple risk scenarios
• Comfortable with rapid throughput and high volumes of studies regardless of complexity
• Accustomed to expedited startup, efficient enrollment and truncated closeout
• Specialized in working hand-in-glove with clinics to manage the specific challenges associated with early phase studies, including the criticality of assessment timing, blood draws and data for dose escalation meetings
• Proficient with the technical aspects of pharmacokinetic (PK) and pharmacodynamic (PD) data collection and management
• Experienced in safety surveillance, having skilled investigators and pharmacovigilance team members to ensure thoughtful oversight of all participants’ safety
• Adept at organizing and adhering to a robust dose escalation or safety review process to ensure patient safety and efficient progression between design and patient populations in adaptive protocols

Through our dedicated early delivery model, our early development services are solely focused on the needs of early clinical development clients to enable the delivery of milestones and commitments.

What differentiates our early development services from others in this space?

The PPD™ clinical research business of Thermo Fisher Scientific has access to integrated, end-to-end clinical trial support and delivery solutions.

We continue to invest in the expansion of early development services by adding new sites, expanding our ability to support a variety of therapeutic areas (e.g. organ impairment, CNS and rheumatology), special populations (e.g. ethno-bridging and lactation studies) and new patient capabilities.

With a focus on continuous improvement, we are investing in technologies that drive greater quality at these units and enable a more seamless and efficient end-to-end journey for our sponsors’ clinical trial data.

While our early development organization, comprised of more than 800 professionals, is dedicated to Phase I and Phase Ib clinical trials, the fully integrated clinical drug development process utilizes more than 30,000 colleagues who bring a broad range of expertise across numerous therapeutic and functional areas.

How can using our early development services detect potential challenges in a drug’s development?

Our early development organization’s expanded offerings in Phase Ib patient trials to characterize the pharmacokinetics and pharmacodynamics in patients and to assess safety and early efficacy signals.

Our Human Safety Committee reviews first-in-human and other high-risk protocols to ensure that the safety profile and procedures are aligned with the team’s safety risk tolerance profile. Working with our principal site investigators, pharmacovigilance medical monitors and therapeutically aligned physicians in our medical organizations enables us to ensure patient safety throughout the trial design and execution.

Partner with a global team of early phase clinical trial experts

With nearly 40 years of experience in Phase I and Phase Ib trials our early development teams work with you to identify potential pitfalls and set your molecule up for success in later-phase programs by accelerating development timelines and containing costs.

We have three clinical research units, located in Austin, Texas, Orlando, Florida, and Las Vegas, Nevada. We also have a network of more than 50 global Phase I research sites, including 26 in the United States, making drug development programs widely accessible to healthy patients, volunteers and specialty populations.