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Worldwide Clinical Trials Early Phase Services

Morrisville, NC, US

Worldwide is the first customer-centric CRO. Founded by physicians dedicated to advancing medical science and built on an unwavering commitment to operational excellence, we are able to strategically balance science, medicine, operations, and commercial intelligence to achieve successful drug development.

We take a never satisfied approach. Tackling every clinical research program as an opportunity to demonstrate a deep commitment to each client’s unique needs. Combining therapeutic expertise – most notably in Neuroscience, Cardiovascular, Immune-Mediated Inflammatory Disease, and Rare Disease – with proactive insights and rigorous operations, we successfully manage clinical trials across more than 60 countries.

Our mission is to foster the development of life-changing medicines by integrating clinical trial methodology, operational acumen, and efficient technology.

**Our Clinical Research Unit for Early-Phase... Show more »

Worldwide is the first customer-centric CRO. Founded by physicians dedicated to advancing medical science and built on an unwavering commitment to operational excellence, we are able to strategically balance science, medicine, operations, and commercial intelligence to achieve successful drug development.

We take a never satisfied approach. Tackling every clinical research program as an opportunity to demonstrate a deep commitment to each client’s unique needs. Combining therapeutic expertise – most notably in Neuroscience, Cardiovascular, Immune-Mediated Inflammatory Disease, and Rare Disease – with proactive insights and rigorous operations, we successfully manage clinical trials across more than 60 countries.

Our mission is to foster the development of life-changing medicines by integrating clinical trial methodology, operational acumen, and efficient technology.

Our Clinical Research Unit for Early-Phase Studies

Established in 2005, Worldwide’s Clinical Research Unit in San Antonio, TX, has 300 beds and a staff of 250 support personnel, including highly trained medical experts who are onsite 24/7 during all trials to monitor more than 10,000 study participants per year.

The site offers limited access Phase I and telemetry units and is certified under the Clinical Laboratory Improvement Amendments (CLIA). It has adaptable procedure spaces and a fully equipped sample processing lab that delivered 600,000 samples in a recent year. In addition, the pharmacokinetics lab features 14 centrifuges and handles more than 300,000 samples per year.

Within the facility is a 1,200 square-foot pharmacy with an ISO Class 7 clean room and ISO Class 5 laminar flow hood. The pharmacy operates under GCP, USP 797, and FDA cGMP Guidance for Phase I investigational drugs. Its compounding suite houses analytical balances with capabilities as low as 2 mg.

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Worldwide Clinical Trials Early Phase Services has not listed any services.

Medical Device Clinical Trials
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Phase I clinical trials
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Our Early Phase Services’ staff has enrolled thousands of participants for both inpatient and outpatient trials. Our staff works closely with you to customize data entry and other processes to meet your specific needs. Our 85,000-square-foot center in San Antonio, Texas, contains extensive security measures to ensure that study... Show more »

Our Early Phase Services’ staff has enrolled thousands of participants for both inpatient and outpatient trials. Our staff works closely with you to customize data entry and other processes to meet your specific needs. Our 85,000-square-foot center in San Antonio, Texas, contains extensive security measures to ensure that study drug supplies, patient information, study samples and associated documentation remain confidential and secure.

Our ability to accommodate large study populations or multiple cohort trials, combined with our dedicated, experienced staff, enables effective integrated planning and implementation for Phase I-IIa clinical trials.

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Patient Recruitment
Price on request

Expertise in Successful Patient Recruitment & Retention

KEEPING ENROLLMENT TARGETS ON TRACK

Industry data suggests that up to 80 percent of clinical re-search studies fail to meet their enrollment targets and fall behind1, risking timely and successful completion of a study. A carefully planned patient recruitment and... Show more »

Expertise in Successful Patient Recruitment & Retention

KEEPING ENROLLMENT TARGETS ON TRACK

Industry data suggests that up to 80 percent of clinical re-search studies fail to meet their enrollment targets and fall behind1, risking timely and successful completion of a study. A carefully planned patient recruitment and retention strategy can keep enrollment targets on track, while reducing time from site initiation visit (SIV) to first patient, improving screening and recruitment rates, and increasing the cost-effectiveness of site activation

OUR PATIENT RECRUITMENT & RETENTION SERVICES

Worldwide’s professional staff offers decades of experience in strategic, proactive patient recruitment methods. Our team also collaborates closely with well-qualified vendor partners who can support a wide range of global programs, including study website development, advertising placement, brand development, mobile app and text messaging services, and site and patient payment processing. Our services are fully compliant with local regulatory requirements and adaptable to site-specific preferences, and include:

SITE ENROLLMENT

• Development of realistic patient recruitment goals.
• Targeted plan for reaching and recruiting the appropriate patient population
• Recruitment and protocol training to ensure quick study start-up

STUDY BRANDING

• Recognizable, memorable and consistent look-and-feel and messaging across all channels, both in digital and in print
• Region and site-appropriate materials, including presentations, patient and physician letters, site posters, appointment reminder cards, and
technical brochures.
• Educational materials, including study brochures, guides and flip charts

STUDY WEBSITE

• Development of website architecture and content plan
• Featuring educational and patient-focused information to raise study awareness

• Integration of pre-screening questionnaire and referral tracking
• Two-way communication enabled through “Live Chat” and call center features

ADVOCACY OUTREACH

• Outreach to patient advocacy groups locally, nationally, and globally
• Involvement with community organizations
• Engagement with patient and family support groups

ADVERTISING

• Creative execution, media planning and targeting ongoing optimization and analysis
• Traditional advertising, including television, radio, print, and direct mail
• Mobile and digital advertising including paid search, geo-targeting, digital display and banner ads remarketing programs, and paid social

PATIENT RETENTION PROGRAMS

Consistent timely communication to patients

• Utilization of mobile technology including SMS text and mobile apps
• Appreciation/incentive programs within IRB guidelines
• Travel assistance and automated payment options

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Clinical PK/PD Studies
Price on request
  • Determining the effects of dosing regimen, patient demographics, etc. on pharmacokinetics
  • Interim safety and pharmacokinetic analysis for early phase/first-in-man studies
  • Experience in ADME studies, plasma and urine pharmacokinetics, dose escalation (SAD), multiple dose (MAD), toxicokinetic (preclinical), first-in-man, bioavailability and bioequivalence
  • Determining the effects of dosing regimen, patient demographics, etc. on pharmacokinetics
  • Interim safety and pharmacokinetic analysis for early phase/first-in-man studies
  • Experience in ADME studies, plasma and urine pharmacokinetics, dose escalation (SAD), multiple dose (MAD), toxicokinetic (preclinical), first-in-man, bioavailability and bioequivalence
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Bioequivalence
Price on request

Early Phase Services’ comprehensive services for bioequivalence studies include protocol design and development, clinical conduct, bioanalysis and statistical analysis. Our final study reports for FDA submission are produced using Liquent InSight Publisher™, which automatically compiles source documents with varying file formats... Show more »

Early Phase Services’ comprehensive services for bioequivalence studies include protocol design and development, clinical conduct, bioanalysis and statistical analysis. Our final study reports for FDA submission are produced using Liquent InSight Publisher™, which automatically compiles source documents with varying file formats into one seamless publication.

This technology also supports reporting from Thermo Electron Watson™ LIMS and other software programs.

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Biostatistics
Price on request
  • Design and implementation of randomization scheme
  • Development of Statistical Analysis Plan (SAP)
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology
  • SAS programming for tables, listings and... Show more »
  • Design and implementation of randomization scheme
  • Development of Statistical Analysis Plan (SAP)
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology
  • SAS programming for tables, listings and figures
  • Production of tables, listings and graphs in compliance with ICH guidelines
  • Performance and validation of statistical analysis
  • Interim analysis
  • Bioequivalence
  • Linear and non-linear modeling
  • Parametric and non-parametric analysis of clinical and PK endpoints
  • Production of statistical report/assistance with clinical report
  • Statistical management throughout the project
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Toxicokinetic Analysis
Price on request
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Bioavailability Studies
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PK/PD Modeling
Pharmacokinetics/Pharmacodynamics Modeling
Price on request
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