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Endometriosis Research, Clinical Study Design & Methodology

Clinical Women's Health Research Services

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CRS Endometriosis Clinical Research

We are dedicated to revolutionizing treatment approaches for women affected by endometriosis. Our biostatistics and methodology specialists support clinical programs from early development through all study phases, providing strategic guidance for study protocols — including gynecological assessments, sample size determination, study objectives, and endpoint definition — ensuring scientific rigor and alignment with regulatory expectations.

  • Statistical support across the full drug development cycle, from early clinical phases onward

  • Expertise in complex gynecological methodology, adaptive approaches, and handling missing data

  • Extensive experience supporting regulatory advisory meetings and clinical trial authorization processes
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Who This Service Is For

We support pharmaceutical sponsors, biotech companies, and academic institutions seeking robust clinical study design and evidence-based research in endometriosis and women's health. We rely on our expertise to minimize risk, optimize study quality, and maintain scientific rigor throughout the clinical program.

What This Service Is

Our Endometriosis Clinical Research service provides scientific, data-driven guidance across every stage of clinical development. We support sponsors with study protocol design, sample size determination, endpoint definition, gynecological assessment strategy, and alignment with global regulatory expectations including FDA and EMA.

Our Capabilities

Our comprehensive endometriosis research and study design capabilities include:

  • Gynecological Examination
  • Transvaginal Ultrasound
  • Vaginal Cytology
  • Endometrial Biopsy
  • Insler Score and Hoogland Score assessments
  • Monitoring of Follicular Growth/Ovulation
  • Rating Scales/Questionnaires: Assessments for quality of life, sleep quality, and pain levels
  • Comprehensive central laboratory partnerships for standardized safety examinations and hormone assays
  • Five experienced, board-certified gynecologists conducting in-house examinations
  • Specialized providers for analyzing PAP smears and endometrial histology
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Why Choose hVIVO?

We deliver the combined strength of a full-service CRO and specialist women's health team to deliver robust and interpretable results. We bring decades of multidisciplinary expertise and a commitment to quality that helps clients control timelines and costs without compromising scientific rigor.

Our state-of-the-art early phase units ensure adherence to Good Clinical Practice (GCP) standards set forth by the FDA and the European Medicines Agency (EMA). Our multidisciplinary team of scientists, medical experts, statisticians, and medical writers tirelessly translates research findings into meaningful advancements that improve the quality of life for patients with endometriosis.

We support studies from early development through postmarketing.

Yes. We actively engage in scientific advisory meetings with regulatory bodies to ensure rigorous adherence to strict scientific standards.
Yes. Our team is experienced in adaptive approaches, complex statistical methodology, and handling missing data across all trial phases.
Yes. We specialize in endometriosis, PCOS, contraception, heavy menstrual bleeding, hormone replacement/postmenopausal status, sexual dysfunction, uterine fibroids, and in vitro fertilization.

Speak with our endometriosis research specialists

Join us in pioneering new paths for endometriosis treatment and research