Women’s Health Clinical Trials and Tech Solution Unveiled

Lindus Health has launched its “All-in-One Women’s Health CRO” offering of contract research organization (CRO) and technology solutions bespoke to running clinical trials for women’s health products.

Women have an increased risk of developing such diseases as breast cancer, osteoporosis, autoimmune disorders, and more. They may also experience very different treatment responses to medications than men due to hormone fluctuations, reproductive health, and other biological factors that must be accounted for in clinical trials for women’s health interventions. Lindus Health is familiar with these nuances, and designs and executes women’s health research effectively.

Lindus Health’s “All-in-One Women’s Health CRO” solution harnesses its CRO and site services and is built on its experience operating women’s health clinical trials. The firm’s multi-pronged recruitment tactics include screening from a repository of more than 30 million electronic health records (EHRs), digital marketing, and collaborations with primary care, women’s health clinics, and community groups. These capabilities enable sponsors to recruit diverse cohorts of participants twice as fast as traditional CROs in all study environments, including site-based, hybrid, and fully virtual settings.

To date, Lindus Health has enrolled more than 2,500 patients in women’s health clinical trials within the United States, United Kingdom, and Europe. Its offering provides companies developing treatments and diagnostics for women’s health conditions with everything needed to manage their trials end-to-end, covering a wide range of indications such as pregnancy, postpartum depression, ovarian cancer, sexually transmitted infections (STIs), and more.

“Women have historically been underrepresented in clinical research, resulting in significant treatment disparities,” said Emma Ogburn, vice president of Clinical Operations of Lindus Health. “Here at Lindus, it’s paramount that we help sponsors develop safe and reliable therapies for women by enrolling diverse, representative study populations while taking into account the unique aspects of their biology.”

The “All-in-One Women’s Health CRO” package equips women’s health sponsors with a broad range of features to enhance their research:

• End-to-end CRO services: From study initiation to completion, Lindus’ clinical operations team manages all project-related and administrative activities for women’s health trials.
• Advanced recruitment strategies: Leveraging partnerships with primary care and women’s health practices, EHR screening, digital marketing, and more, Lindus employs cutting-edge recruitment methods to quickly enroll diverse trial populations for women’s health studies.
• Flexible eClinical platform: Citrus, Lindus’ proprietary clinical research management technology designed for each individual study, integrates essential tools such as clinical trial management software (CTMS), electronic data capture (EDC), telehealth, eConsent, and much more, providing everything needed for efficient trial management.
• Expansive industry and regulatory knowledge: Lindus offers expert guidance in regulatory requirements and industry trends relevant to the women’s health market segment.
• Robust site services: Lindus’ site operations team collaborates closely with principal investigators (PIs) and research teams to successfully manage women’s health trials across various formats, including single-site, multi-site, virtual/hybrid, and traditional setups.

“Lindus has been a great partner in helping us conduct our clinical research,” Spark Biomedical Chief Scientific Officer Dr. Navid Khodaparast commented. “Their clear communication and proactive approach of handling all the ‘what ifs’ sets them apart from other CROs we’ve worked with. We really enjoy collaborating with them.”

Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers, bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a clinical operations team with its unique software platform, and access to more than 30 million EHRs. 

Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

To date, Lindus Health has delivered clinical trials to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised more than $24 million from investors including Peter Thiel, CREANDUM, Firstminute Capital, Seedcamp, Hambro Perks, Amino Collective, and Calm/Storm.