Wellness
Lindus Health introduces CRO for clinical trials in women’s health
Lindus Health has launched its “All-in-One Women’s Health CRO” offering of contract research organisation (CRO) and technology solutions bespoke to running clinical trials for women’s health products.
Women have an increased risk of developing certain diseases like breast cancer, osteoporosis, autoimmune disorders, and more. They may also experience very different treatment responses to medications than men do.
This is all 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’s “All-in-One Women’s Health CRO” solution harnesses its comprehensive CRO and site services and is built on their extensive experience in operating women’s health clinical trials. Its multi-pronged recruitment tactics include screening from a repository of over 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 over 2,500 patients in women’s health clinical trials across the US, UK, and Europe. Their comprehensive 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 including:
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,” said Dr. Navid Khodaparast, Chief Scientific Officer at Spark Biomedical. “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.”
Wearable technology could revolutionise how women understand and manage their menstrual and hormonal health, according to a major new review that assessed dozens of studies involving data from millions of participants.
The review, which examined 40 studies with cohorts ranging from small pilot groups to nearly 19 million participants, found that devices such as the Oura Ring, Apple Watch, Fitbit, WHOOP band and Garmin watches are capable of detecting meaningful physiological changes across the menstrual cycle – and could one day help identify conditions far sooner than current methods allow.
The findings come as growing attention is being paid to the economic and personal toll of menstrual health problems.
Up to 90 per cent of women report cycle-related symptoms including pain, bloating and mood swings, while up to 40 per cent suffer from premenstrual syndrome.
A more severe condition, premenstrual dysphoric disorder, affects up to 8 per cent of women. In economic terms alone, menstrual and perimenopausal symptoms are estimated to cost the United States more than US$26 billion a year.
Researchers found that wearables were able to reproduce well-established hormonal patterns in real-world settings.
Skin temperature was found to be lower in the first half of the cycle before ovulation, and higher afterwards, consistent with known effects of progesterone.
Resting heart rate rose by around two to four beats per minute from the pre-ovulation phase to the days following it.
Heart rate variability, a marker of nervous system activity, was highest in the early cycle and lowest in the premenstrual phase, with lower readings linked to symptoms of PMS and PMDD.
The review also challenged some long-held assumptions.
Digital data suggested that ovulation tends to occur later and more variably than previously thought, with the pre-ovulation phase averaging 15 to 17 days rather than the 13 to 14 days typically cited.
Skin temperature was also found to dip most sharply more than five days before ovulation – not immediately before it – a finding the authors said could have practical implications for women using cycle tracking for contraception or conception.
Large datasets revealed that cycle patterns vary considerably between individuals and across a lifetime.
Nearly 20 per cent of women showed significant cycle-to-cycle variability, and both low and high body weight were linked to longer and less predictable cycles.
The data also pointed to racial differences in menstrual characteristics that had previously gone largely undetected in smaller laboratory studies.
On contraception, the review found that combined hormonal contraceptive users showed flatter, inverted heart rate variability patterns across the cycle, while progestin-only methods produced trends closer to natural cycles.
The authors cautioned that most research has been conducted in the United States and Europe, with predominantly white participants, and called for broader, more diverse studies.
They also flagged significant gaps in research on perimenopause, partly because many studies excluded women with irregular cycles.
Despite these limitations, researchers concluded that wearable devices hold genuine promise for helping women monitor their health and enabling earlier identification of conditions that might warrant medical attention – provided privacy safeguards and standardised research methods are put in place.
Gum disease may impair female fertility by triggering inflammation that affects the ovaries and egg quality, a study in mice suggests.
The findings point to a possible biological link between oral health and unexplained infertility.
Researchers said chronic oral inflammation was linked to oxidative damage, disrupted follicle development and reduced live birth rates in mice.
The study was led by prof Michael Klutstein at the Hebrew University of Jerusalem and prof Asaf Wilensky at the Hebrew University-Hadassah Medical Center, with students Dr Paz Kles and Stephen Ameho.
Scientists examined inflammation linked to dental implants in a mouse model, a common clinical scenario, meaning the research was carried out in animals rather than people.
They tracked how immune signals moved through the body and found the inflammation did not appear to stay confined to the mouth.
Instead, it triggered a systemic immune response, meaning an immune reaction across the body, that reached the ovaries.
The animals had increased levels of inflammatory cytokines in the ovaries. Cytokines are proteins used by immune cells to send signals during inflammation.
Researchers also found changes in immune cell populations, oxidative damage to ovarian tissue, impaired follicle development and reduced oocyte quality.
Oxidative damage happens when harmful molecules damage cells. Oocytes are immature egg cells, while follicles are small structures in the ovaries that contain developing eggs.
These biological changes were linked to reduced live birth rates under inflammatory conditions.
The study also found that oocytes showed DNA damage and epigenetic alterations similar to those seen in reproductive ageing.
Epigenetic changes affect how genes behave without changing the underlying DNA code.
Prof Klutstein said: “Inflammation is often thought of as a localised response, but our findings show that it can have systemic consequences that extend as far as the reproductive system.
“This work suggests that chronic oral inflammation may be an underrecognised factor in female infertility, potentially contributing to cases that currently have no clear explanation.”
The researchers said the findings add to growing evidence linking oral health with overall health.
Chronic oral inflammatory conditions, such as periodontitis, are widespread and have previously been associated with systemic diseases.
Periodontitis is a severe form of gum disease that can damage the tissue and bone supporting the teeth.
The authors said further research in clinical settings would be needed to understand whether the findings translate to patient care.
If confirmed in humans, they said the work could support new approaches to diagnosis and treatment, including anti-inflammatory or antioxidant strategies aimed at improving fertility outcomes.
Women over 40 are seeking raves for mental and physical wellbeing, with a study suggesting the benefits go beyond nightlife.
The findings challenge the idea that nightlife and electronic dance music events are mainly for younger people.
Published in Psychology of Music, the study focused on the common misconception that nightlife is only for younger audiences.
Researchers surveyed 136 female clubbers aged 40 to 65 about their experiences at electronic dance music events.
The study, carried out at the University of Leeds in England, found women reported mental and physical wellbeing benefits from attending these events.
Seeing favourite DJs was the most common motivation, but many women also described dancing as a way to relieve stress and find emotional support.
The research found that 65.9 per cent of participants described attending a rave as “spiritual”, while 62.9 per cent said it offered an escape from everyday life.
A further 58.3 per cent said they felt like a different version of themselves in a club environment.
Nine in ten participants said they felt at home at electronic dance music events, with many pointing to a shared passion for music and the sense of community around it.
The study also suggested physical fitness played a role, with some women saying they had made clubbing part of their regular exercise routine.
However, the findings also highlighted challenges for older women in nightlife spaces.
One fifth of participants said they felt visibly out of place because of their age.
Nearly half reported unwanted physical contact, leading some to seek out different venues or attend only with friends.
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