Early Phase/Phase I Development



In a report conducted annually by Industry Standard Research, pharmaceutical and biotech organizations indicated the characteristics that matter most when evaluating early phase CRO providers include all the standard qualities such as responsiveness, timely communications, operational excellence, and seamless recruitment.

However, for an early phase CRO to truly make a difference, we know that you expect your provider to go beyond the status quo. You need a CRO that exceeds expectations when it comes to the hard parts of your program, such as access to unique tests, a staff that understands and has access to your patient populations, and deep-rooted expertise in healthy volunteer and patient recruitment.

Worldwide’s Clinical Pharmacology Unit is different. We’re not status quo.

We are supplemented by a network of 10 U.S. clinical pharmacology sites that conduct studies in patients and specialty populations. In the past five years, our early phase network sites have participated in more than 60 studies.

We are nimble. Our recruitment and screening solutions allow us to rapidly enroll both healthy and patient volunteers into early phase studies, without all the hassle. Our uncommon approach includes:

  • A comprehensive database of more than 230,000 healthy volunteers, including post-menopausal women, elderly, and obese populations
  • CPUs located in large metropolitan areas near major universities
  • 50 percent repeat volunteer base
  • SMS text outreach, used for recruiting and scheduling reminders
  • Real-time advertising to recruit healthy volunteers and chronic ambulatory patients, including those with diabetes and nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH)

An internal patient recruitment group specialized in novel digital patient recruitment techniques.

Learn more about Worldwide’s Full-Service Clinical Research Unit.


early phase/phase 1 clinical trial development

Take a tour of Worldwide’s Clinical Pharmacology Unit:

  • Limited-access Phase I unit
  • cGMP Phase I pharmacy
  • Full-service clinical laboratory
  • Fully equipped sample processing laboratory
  • And More


Hepatic Impairment

We distinguish between hepatic impairment related to alcohol abuse and that associated with nonalcoholic fatty liver disease (NAFLD). Subjects are recruited according to Child-Pugh scores, typically having ratings of A or B because patients with Child-Pugh scores of C tend to be too sick to participate in clinical trials.

Learn more about our services for endocrine and metabolic indications.


Nonalcoholic steatohepatitis (NASH) is a progressive fatty liver disease that causes damage similar to that caused by alcoholic hepatitis. With many NASH patients on track for transplantation, sufficient recruitment requires a broad access to subject populations and an established track record in patient safety.

Learn more about Worldwide’s services in NASH research.

Renal Impairment

Assessments of patients with renal impairment are typically classified into mild (GFR 50-80 ml/min), moderate (GFR 20-50 ml/min), or severe (GFR<30 ml/min). Access to subjects with severe renal impairment is limited because most of these patients are on track for transplant and receiving dialysis treatment; however, it is possible to recruit small numbers. Such end-stage renal disease patients are recruited and studied only in concert with their primary medical care provider or a dialysis treatment center.

Learn more about Worldwide’s services for endocrine and metabolic indications.


With the typical age range for subjects in hypertension studies spanning 35 to 80, studies require access to patient populations across a wide age demographic. With our large database of volunteers, and using both traditional and novel recruitment techniques, Worldwide has access to patients meeting all demographic criteria.

Learn more about Worldwide’s services for cardiovascular indications. Learn more about our partnership with phaware Global Association in our webinar, “Reconstructing the Rare Disease Paradigm.”


The field of geriatric health addresses concerns of patients over 60 years old. The challenge for these studies is to achieve a broad and representative range of ages within the elderly population because patient populations become progressively smaller with advancing age. Today’s expanding aging population increases the availability of geriatric patients, while at the same time amplifying the demand for new treatments of age-related diseases.

Learn more about Worldwide’s early phase program services.


Obesity-related studies are concerned with patients having a BMI of 35 or higher. As the condition affects patients from all age groups, and can be related to a variety of indications, these studies may require access not only to healthy adults but also to special populations, such as pediatrics or geriatrics.

Learn more about how Worldwide can support your obesity study.

First-in-Human Studies

For your first-in-human study, where there is potential for great breakthroughs, meticulous trial design and execution are imperative. Trial protocols and resulting data must be established strategically, anticipating the requirements of later phases of the investigation. Patient safety is critical in the early phase; therefore, recruitment of sufficient subject numbers requires reassurance of a high level of care throughout the study process.

Learn more about Worldwide’s services related to early phase trials.

Cardiac Safety

Worldwide Clinical Trials has a state-of-the-art clinical research facility located in San Antonio, TX, with on-site crash carts for premier cardiac safety. Certified under the Clinical Laboratory Improvement Amendment (CLIA), the facility can provide adaptable procedure spaces and has a capacity of 180.



Make informed decisions, faster with Worldwide Clinical Trials’ Bioanalytical Laboratory