Application Notes & Case Studies

1. Actigraphy For PTSD 1/22/2020

   The relationship between PTSD and sleep disruption is complex. Sleep patterns of those with PTSD likely fluctuate over time depending on the chronicity of PTSD, nature of trauma, comorbid conditions, and medication usage. Actigraphy is thus ideally suited to studying these patterns as it is precise, non-invasive, objective, and provides continuous data over periods of weeks or months.

2. Actigraphy For Multiple Sclerosis 1/21/2020

   Activity patterns of those with multiple sclerosis (MS) fluctuate over time according to exacerbations and remissions, and therefore represent an important marker of disease progression. Read how actigraphy can be used to to measure conventional activity, sleep, and circadian endpoints and more to assist in studies.

3. Actigraphy For Fibromyalgia 1/21/2020

   Fibromyalgia (FM) is a neuropathic pain that affects millions of people in the United States. It, like most pain conditions, affects daily activity and sleep. The pain sensations are best measured by recording the patient’s own perceptions (patient-reported outcome) but the related effects of pain on activity and sleep can be measured objectively with actigraphy. Read how actigraphy provides useful insights into the activity patterns in patients with fibromyalgia.

4. Actigraphy For Breast Cancer 1/21/2020

   Actigraphy is the measurement of motion used to monitor 24-hour activity patterns. Read how actigraphy was used in breast cancer studies to track sleep patterns, circadian endpoints as well as using datasets provided to investigate mathematical patterns which may be responsive to pharmacological therapy.

5. Actigraphy For Alzheimers 1/21/2020

   Alzheimer’s disease is a cognitive impairment, but it can manifest itself in many detrimental ways including alterations in daytime activity levels, sleep quality, and awake/sleep patterns. Read how actigraphy can provide important data when studying patients with Alzheimer's disease.

6. Lucky CRAs. Getting Automated To-Do Lists For Targeted SDV 1/21/2020

   Data managers at Lotus Clinical Research used to spend hours each week building reports to identify the patients and forms that needed Source Data Verification (SDV) at the next site monitoring visit. To tackle the problem, Veeva Vault EDC introduced QuickView, a dynamic interface that optimizes the display of data by function, allowing users to focus on what matters most.

7. Satisfying Aggressive Timelines With A Simplified Supply Chain For Drug Delivery 1/10/2020

   To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route.

8. Prostate Cancer Clinical Utility Study 1/2/2020

   To further enhance their prostate cancer test, a multinational healthcare company needed to compare its non-invasive urine test against biopsied tissues. But the logistics of identifying 2,000 patients and collecting tissues at 21 US urology centers within 6 months was daunting. Read how quick response by Catalyst and the geographic alignment of the team the study was completed within a short window of time.

9. Scaling Biometrics FSP 1/2/2020

   A small biotech was purchased by a large multinational biopharmaceutical company and shortly thereafter closed the office of the former, leaving little to no resources for ongoing statistical programming to ensure continuity for their robust clinical development programs. To ensure limited disruption of the program, the Sponsor engaged Catalyst to assume statistical programming services as they had no internal resources to dedicate. With Catalyst proving the ability to scale and provide exceptional programming talent the partnership continues to expand.

10. Phase III Rare Disease Rescue 1/2/2020

    A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections. After nearly 16 months, patient enrollment was still a major challenge, the study was over budget and CRO staff turnover on the project was extremely high. Catalyst provided a blinded and unblinded monitoring team that reported into the Sponsor’s CTM using Catalyst’s SOPs allowing the Sponsor to retain control of their program.