B. McLaughlin Associates, Inc. Clinical Research Organization (CRO) - Study Management - Data Management - Regulatory Document Collection - Project Management
B. McLaughlin Associates, Inc. (BMA) has been a provider of customized, cost-effective clinical research support for over 18 years. Our services for drug, biologics, and device studies include Study Management, Regulatory and Financial Document Collection and Review, Regulatory Document Audits, Clinical Study Contract/Patient Budget Negotiation, Informed Consent Creation, Review and Change Management, Drug and Biologics Temperature Monitoring (Cold Chain), Data Management, and Clinical Scientist Support.
We recognize the importance of a successfully run clinical trial and have the industry experienced staff to enhance your study team and create positive results. Our Study Analysts, Data Analysts, and Study Managers will professionally run your projects to ensure timely completion of all contracted tasks, while keeping quality, accountability, and compliance paramount. Whether your outsourcing requirements are for the full life cycle of a clinical trial or just for a specific need, BMA is here to provide a flexible solution.
Our goal is to provide world class support services that keep your projects on time, within budget, and compliant to all regulatory authorities.
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
B. McLaughlin Associates, Inc. (BMA) has been a provider of customized, cost-effective clinical research support for over 18 years. Our services for drug, biologics, and device studies include Study Management, Regulatory and Financial Document Collection and Review, Regulatory Document Audits, Clinical Study Contract/Patient Budget Negotiation, Informed Consent Creation, Review and Change Management, Drug and Biologics Temperature Monitoring (Cold Chain), Data Management, and Clinical Scientist Support.
We recognize the importance of a successfully run clinical trial and have the industry experienced staff to enhance your study team and create positive results. Our Study Analysts, Data Analysts, and Study Managers will professionally run your projects to ensure timely completion of all contracted tasks, while keeping quality, accountability, and compliance paramount. Whether your outsourcing requirements are for the full life cycle of a clinical trial or just for a specific need, BMA is here to provide a flexible solution.
Our goal is to provide world class support services that keep your projects on time, within budget, and compliant to all regulatory authorities.
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
1. This presentation is provided to you by BMA. The presentation is meant to enhance discussions between your organization and BMA. The substance of this presentation is confidential and is legally privileged. BMA Core Capabilities Presentation
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3. locations PENNSYLVANIA 1540 McDaniel Drive West Chester, PA 19380 Tel. 610.430.1847 Fax 610.430.1970 ARIZONA 16515 South 40th Street Suite 125 Phoenix, AZ 85048 Tel. 480.659.9120 Fax 480.659.9193
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5. 18 years of therapeutic expertise Biologics Cancer HSV Breast HPV Lung (Non-Small Cell) Influenza Melanoma Pertussis Myeloid Leukemia, Acute Polio Diphtheria Tetanus Hepatitis B Cardiovascular Atrial Fibrilation Congestive Heart Failure (CHF) Congestive Heart Failure (CHF), Pediatric Coronary Heart Disease CNS Cancer – Brain Insomnia Restless Leg Syndrome, Adolescent Progressive Multifocal Leukoencephalogy Dermatology Psoriasis Wound Healing Endocrinology Diabetes Type 1 Diabetes Type 2 Diabetes Type 2, Pediatric Gastroenterology Cancer – Gastroesophageal Hematology Idiopathic Thrombocytopenia Purpura Lymphocytic Leukemia, Chronic Non-Hodgkin’s Lymphoma Thromboembolism Prevention Infect. Disease Diphtheria Otitis Media Hepatitis B Pertussis Hepatitis C Pneumonia HSV Polio Musculoskeletal Cancer – Sarcoma, Soft Tissue Disease Nephrology Cancer – Renal Cell Hepatitis C Liver Disease, Chronic Oncology Brain Lymphocytic Leukemia Breast Melanoma Cervix Myeloid Leukemia, Acute Colorectal Non-Hodgkin’s Lymphoma Esophagus Other Gastric Ovary Head and Neck Prostate Kaposi’s Sarcoma Renal Cell Lung (Non-Small Cell) Soft Tissue Lung (Small Cell) Solid Tumors Ophthalmology Cancer Safety Follow-up Other Chemo-Induced Nausea & Vomiting Post-Surgical Nausea & Vomiting Respiratory Asthma Cancer – Lung Chronic Obstructive Pulmonary Disease Urology Benign Prostatic Hyperplasia Cancer – Prostate Women’s Health Cancer Breast Cervix Ovary HPV
7. why BMA? sized by design, we offer… Valued Service – High quality, specialized support with a personalized approach. Tailored service, consistency and expertise not always found in a larger organization. Flexibility – Through strategic partnerships, BMA has the ability to ramp up quickly or scale back and maintain a skilled staff pool. Once an MSA is in place, BMA can begin project work very quickly, sometimes in less than 24 hours. Innovation – Routinely create and implement new processes and/or improve upon existing client processes
8. why BMA? sized by design, we offer… Partnership – Integration of BMA operations with client’s team utilizing laptops, client and CRO systems and training. Very experienced in working with and auditing other vendors, CROs and sites. Big Picture Approach – Results-driven, cross-functional team members provide greater insight and understanding of the projects as a whole, not just our designated tasks Continuity – Lower attrition rates allow for dedicated staff to be maintained throughout the course of the project, providing greater stability and fostering strong team relationships
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14. case study: study management opportunity Sponsor had 82 sites that needed to be ready to enroll in a very short time for a high profile cardiovascular study. Sponsor had a limited study budget and departmental resources and needed a company that could come on board quickly and execute results. BMA was contracted to distribute, collect and review regulatory documents. plan Following federal guidelines, sponsor SOPs, processes, and guidance documents in conjunction with BMA SOPs, BMA prepared Study Initiation Pack (SIP) documents, created SIP binders, verified site information and disseminated Initiation packets for sponsor. Also collected, reviewed and tracked regulatory documents for Sponsor Regulatory Approval. results Regulatory Documents disseminated, collected, reviewed, tracked and confirmed as accurate in an average of 25 working days (34 calendar days). Sponsor met target initiation deadlines ahead of schedule and within budget. BMA completed all work within 5 months, more than 5 months ahead of sponsor projections (bulk of the time spent within the first 3 months). Speed and time savings translated into a cost savings of over 60% of the original Sponsor projected budget.
15. case study: study management opportunity Very large oncology vaccine trial that was part of a sponsor initiative to save money and deeply save time to site initiation. Sponsor started trial internally, but lacked the resources to get sites up and running to meet Upper Management’s proposed timelines. Sponsor needed to outsource a portion of the sites to a company that could come on board quickly to send out initiation packets and collect and review regulatory and IRB documents, including Informed Consent Form (ICF) review. plan BMA assumed 40% of the total study sites for 26 weeks. Tasked to prepare Initiation packet documents and binders, verify site information, disseminate packets and procedure manuals, as well as collect, review and track regulatory documents for sponsor regulatory approval and review ICFs pre- and post-IRB submission. results 92% of BMA managed sites were ready for site initiation within 26 weeks. Average of 111 working days (154 calendar days) from initial packet shipment to regulatory approval for BMA versus 193 working days (270 calendar days) for sponsor.
16. case study: contracts & budgets opportunity First time that sponsor contracts group had outsourced contract and budget negotiations. Imperative that CRO work as a seamless extension of sponsor team without sites recognizing a difference between CRO and sponsor. Negotiate and finalize contracts and budgets with sites quickly in order to meet an impending study start. plan Utilizing sponsor SOPs, guidance documents and training in conjunction with BMA SOPs, BMA negotiated contract language and per patient budgets. Given autonomy to approve budgets within the criteria set forth by the sponsor and abiding by standard-of-care amounts. Developed thorough understanding of direct and indirect costs associated with performing the study. The goals were to reduce delays in internal and external budget review and approval. Identified all costs, including "hidden" costs and confirmed that budgets were within range and in sponsor required format. results Met sponsor proposed timelines, negotiating per patient budgets for 124 sites in an average of 36 calendar days and Clinical Study Agreements for 124 sites in an average of 38 calendar days. Through our training and negotiating skills, negotiation was successful and assured that mutual agreement was achieved by all parties.
17. case study: auditing opportunity Sponsor had a very large Phase III oncology trial that had been ongoing for 3 years, was on its 7th amendment and was being submitted for FDA approval. Via internal sponsor review, it was noted that the paper Investigator, Central and Country Regulatory files were missing documents and/or inappropriately filed. BMA was contracted to audit Investigator files and review and file thousands of pages of loose documents as well as perform due diligence. In anticipation of an on-site FDA inspection, the files had to be inspection ready in 3 months. plan Following federal guidelines, sponsor SOPs, processes, and guidance documents in conjunction with BMA SOPs, a team of BMA auditors reviewed all of the miscellaneous documents in comparison to the files, performed a thorough review of all Investigator and Central/Country files, liaised with sites, monitors and internal personnel to resolve document discrepancies and carried out a full due diligence effort. results BMA was able to review all documents, files and perform due diligence according to sponsor requirements within the sponsor’s timeframe. BMA was asked to be involved with the pre-inspection preparedness and was an integral conduit during the time of inspection. No 483’s were observed during inspection and the drug subsequently received approval. From recommendations made by the BMA auditors and with our support, the department developed new Investigator, Country and Central file filing guidelines. Additionally a central file room, internal audit team and audit process were developed.
18. case study: data management opportunity During the review of sponsor’s oncology drug submission, FDA requested that slides for a subset of subjects be re-submitted to a central pathology lab for re-assessment. Sponsor needed specimens collected from 20 countries, 75 sites totaling about 608 slides. Sponsor expectation was that 20% of the needed slides would be recovered. plan Assisted in locating and returning slides from the sites including facilitating activities and tracking communication regarding return of slides. Centrally maintained all communication and documentation of efforts. Facilitated related activities such as shipment of return materials (often requiring knowledge of international shipping and customs requirements related to the shipment of human specimen samples). Provided ongoing progress reports to Study Management. results Proposed deadline of 2 months was met with a 95% response rate from sites regarding the status of the slides. Exceeded sponsor expectations of a 20% return by facilitating the recovery and return of 80% of the outstanding slides.