Alkaline Hematin Biomarker
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The document discusses a method called alkaline hematin for quantitatively measuring menstrual blood loss, which is commonly used as an endpoint in clinical trials for conditions like menorrhagia, endometriosis, and uterine fibroids. The method involves measuring the absorbance of hematin extracted from used feminine hygiene products. KCAS has validated this alkaline hematin assay according to FDA standards and has experience measuring over 137,000 samples from more than 10,000 menstrual cycles using this method. Their validated method and data have supported FDA approval for several drugs and devices.
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1) Mahboob Ali Khan proposes establishing a quality management system and pursuing accreditation for a client hospital from JCI, NABH, and CBAHI.
2) The scope of consultancy services includes gap assessments, developing documentation, training programs, and providing support through the accreditation process over 12 months.
3) The client hospital is expected to commit resources including a dedicated quality team and provide access to records to support the accreditation work.AXIS Clinicals Corporate Presentation
AXIS Clinicals Corporate PresentationAxis Clinicals
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AXIS Clinicals, a privately-owned well established full-service CRO (Contract Research Organization) headquartered in Hyderabad, IndiaEQA: An Essential Tool for Laboratory Quality - Africa LT649 
EQA: An Essential Tool for Laboratory Quality - Africa LT649 Randox
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Laboratory External Quality Assessment - An Essential Tool - Africa Brochure for Randox Quality Control08 Am09 Presentations Kliger
08 Am09 Presentations KligerSimon Prince
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The medical director is responsible for developing, implementing, and overseeing a facility's robust quality assessment and performance improvement (QAPI) program. This includes establishing a multidisciplinary team to regularly review data, prioritize issues, and take corrective actions to improve patient outcomes and safety. The QAPI program must measure and address various clinical areas at minimum, and compliance is determined by reviewing outcomes, records, and interviewing staff.Compare home pulse pressure components collected directly from home
Compare home pulse pressure components collected directly from homeCatherine Liao
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Ram Ramanujan
Diabetic Care Associates
April White (linkedin)
April White (linkedin)April White
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April White has 9 years of experience in healthcare, including as a military medic and clinical laboratory specialist. She is board certified in laboratory technician work and trained in emergency response. Her experience includes performing laboratory tests, phlebotomy, neonatal care, and ensuring compliance with various healthcare standards and regulations. She also has experience supervising other medical staff and implementing new standards and procedures to improve efficiency and quality of care.April White (linkedin)
April White (linkedin)April White
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April White has 9 years of experience in healthcare, including as a military medic and clinical laboratory specialist. She is board certified in laboratory techniques and trained in emergency response. Her experience includes performing laboratory tests, administering immunizations and neonatal care, and training over 100 medical staff. She has a track record of implementing procedures to improve quality of care and ensuring regulatory compliance.Healthcare facility Quality and Operational proposal by Mahboob ali khan MHA,...
Healthcare facility Quality and Operational proposal by Mahboob ali khan MHA,...Healthcare consultant
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Alkaline Hematin Biomarker
- 1. MeasurementofBloodLossbyAlkalineHematin KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com The alkaline hematin technique de鍖nitively and quanti鍖ably determines MBL, and is commonly used for womens health clinical trials as an MBL endpoint for: > Menorrhagia > Endometriosis > Adenomyosis > Uterine Fibroids We performed side-by-side comparisons to determine the accuracy of pictograms (e.g., PBAC) for products currently on the market and our research found that pictograms are not only inaccurate but lead to false conclusions regarding the inclusion or exclusion of subjects into a clinical study. Comparisons have been presented at Womens Health conferences and our posters can be viewed by visiting www.kcasbio.com. The method involves pummeling used feminine hygiene products in a solution and measuring the resulting hematin absorbance against calibration curves. To allow us to rapidly reports results, the historic method was re-tooled and validated in accordance with current FDA Guidance for Method Validations. The validation summary below documents product selectivity, kinetic conversion, calibration design, best 鍖t analysis, precision and accuracy, dilution integrity and stability. MeasurementofBloodLossbyAlkalineHematin Clinical trials for drug therapies or surgical techniques treating menorrhagia, endometriosis, uterine 鍖broids or adenomyosis, often require menstrual blood loss (MBL) measured at screening and post-treatment endpoints as an e鍖cacy marker. KCAS has validated the alkaline hematin biomarker, a rapid spectrophotometric assay, acknowledged as the de鍖nitive MBL e鍖cacy biomarker by regulatory agencies and recognized experts in the womens health 鍖eld. > Experience: Since 2006, KCAS has measured more than 137,000 samples from more than 10,000 menstrual cycles. Our method is validated to FDA Guidance for Validations standards and has been audited by both device and pharma clients. > Logistics: No other lab has the know-how to help you design and facilitate the collection of AH samples across multiple domestic or international clinical sites. > Proven Record: KCAS alkaline hematin data has been a part of multiple NDA submissions that have met FDA approval. KCAS has supported several programs for drugs and devices and our data reporting complies with FDA expectations. KCAS facilitates all aspects of the alkaline hematin project, including: > Generating a custom laboratory manual & patient instructions > Presenting site training at investigator meetings > Creating sample collection kits > Providing kits, storage/shipping containers and shipping materials to clinical sites > Coordinating re-orders and available for on-demand clinical site support Bioanalytical & Biomarker Services We utilize a custom Access/SQL database for data management and reporting that incorporates the unique aspects of multi-site AH clinical trials. The databases speci鍖c report format and frequency is tailored to the clients speci鍖c study design and needs. Methodology Why KCAS? Investigative Logistical Support Indications