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Patient-Centric Strategies

Diversity Initiatives

Our team works with you to design a Program Race and Ethnicity Diversity Plan for the product's lifecycle. Some of our programs include:

  • Partner with community sites and smaller site networks
  • Partner with patient groups and community leaders
  • Real-time translations and tools
  • Train existing sites on cultural fluency
  • Develop patient-friendly technology to make patients more eager to participate
  • Develop marketing materials that connect with the patients who need to see it
  • Expanded reach for Hispanic patients and Native Americans
  • We have an international location in Latin America to support regulatory and operational needs.

Home Visits

If home visits are part of your study; we manage the vendor to ensure your patient has the best experience.

Patient Travel Policy and Reimbursement

Sometimes the reason a patient declines to enroll is as simple as the inability to travel to the site. Don't let that be a reason to lose a patient. We set up car service and reimbursement or direct payment to the provider to fit the needs of each patient.

  • Patient Travel Support for those with disabilities or mobility concerns
  • Community Partnerships (Faith-based organizations, Community influencers, Community leaders)
  • Direct patient reimbursement
  • Home Care

Site Selection and Feasibility

  • Smaller site networks 
  • Community providers and hospitals
  • Rescue/replacement sites

The Current State Of The Industry

High Cost​

This is a challenge not unfamiliar to anyone in the drug development space. Clinical Trial costs are a critical factor while planning portfolio management. Running a drug development company is an expensive endeavor, and even the most altruistic executive must factor in the cost to benefit ratio while selecting compound to advance.

Shelving Of Helpful Drugs​

Many drugs are shelved due to financial concerns, regardless if that medication may have improved the lives of patients. It is a decision never taken lightly and often with great disappointment to the team. Difficult decisions are made to choose which treatments have the best likelihood of reaching patients.

Long Drug Development Process​

The overal time from discovery of a new chemical enitiy to final regulatory approval can be as long as 15-20 year. This often create very short to no patent excusivity.

Complex Protocols

Clinical trial protocol are become more complex as researcher attempt to explore biomarkers and early signals, creating a barrier of entry for many medical practices

Low Success Rates

A small percentage of new drugs receive regulatory approval. In 2018, for example, approximately 14% were approved.

The Drug Development Process

Even with all the changes in healthcare, the drug development process has remained somewhat static. Most companies strive to have the next breakthrough medication. They utilize protocols and statistical designs that require large numbers of patients and sites. Trial costs are a critical factor in the overall process and far too many potentially life-saving treatments are shelved due to financial concerns.

Approximately 14% of all drugs in development obtain approval from the FDA. Previous estimates placed overall success rates, as low as 9%. While the percentage of approvals remains low, the cost of development continues to climb. The average cost per drug is $4 billion. This cost varies significantly among companies with some as high as $25 billion.

1 %
of all drugs in development that obtain approval from the FDA
1 Billion
The average spend per NME
1 Billion
Cost ceiling for some companies per NME

Low patient enrollment rate is a key rate limiter in portfolio management. It is the driver which either extends timelines or requires researchers to open additional sites and countries.

A typical patient enrollment rate is 0.5 patients/site/month, and typical Phase II study will include 400 patients. So for this example, a company has two options: they must either take longer to enroll or include more sites and regions. It’s the age-old time/cost/quality model — pick two.

What if there was another option… higher recruitment rates?

At Corlexia, our sites set us apart from typical site management groups.

They are selected based on their interest in research trials and participate only if they have the patient population and the passion to get involved. Our sites know that if they commit to a study, they can deliver on the enrollment promise. They can do so because they know each of their patients.

We stand behind our promised enrollment targets because it’s based on people, not analytics.

Join the Corlexia Team

We bring all the support you need so you can focus on patient care and trial conduct.

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