Following Guidelines During a Crisis

The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).

The effects of electronic nursing handover on patient safety in the general (non-COVID-19) and COVID-19 intensive care units: a quasi-experimental study.

BACKGROUND: The unprecedented increase in the nurses' workload is one of the issues affecting the quality and safety of patient care in the Intensive Care Units (ICUs). The electronic nursing handover can share sufficient, relevant, and necessary data about patients with greater efficiency and accuracy and prevent their information from being deleted. Therefore, this study aimed to determine and compare the effect of the Electronic Nursing Handover System (ENHS) on patient safety in General ICU and COVID-19 ICU. METHOD: This is a quasi-experimental study conducted during an 8-month period from 22 to 2021 to 26 June 2022 using a test-retest design. A total of 29 nurses working in the General and COVID-19 ICUs participated in this study. Data were collected using a five-part questionnaire consisting of demographic information, handover quality, handover efficiency, error reduction, and handover time. Data analysis was conducted in IBM SPSS Statistics for Windows, version 26 (IBM Corp., Armonk, N.Y., USA) using the chi-squared test, paired t-test, and Analysis of Covariance (ANCOVA). RESULTS: The results showed that the mean scores of handover quality and efficiency, reduction of clinical error, and handover time in the electronic handover were significantly higher than those obtained in the paper-based method. The results showed that the mean score of patient safety in the COVID-19 ICU was 177.40 ± 30.416 for the paper-based handover and 251.40 ± 29.049 for the electronic handover (p = .0001). Moreover, the mean score of patient safety in the general ICU was 209.21 ± 23.072 for the paper-based handover and 251.93 ± 23.381 for the electronic one (p = .0001). CONCLUSION: The use of ENHS significantly improved the quality and efficiency of shift handover, reduced the possibility of clinical error, saved handover time, and finally increased patient safety compared to the paper-based method. The results also showed the positive perspectives of ICU nurses toward the positive effect of ENHS on the patient safety improvement.

[Use of thoracic and lung ultrasound in general anesthesia]. / A mellkas és a tüdo ultrahangvizsgálatának szerepe az általános érzéstelenítés során.

The use of ultrasound became an essential tool in the everyday practice of anesthesiology and intensive care as an indispensable prerequisite for the precise guidance of invasive procedures and also as a point-of-care diagnostic method. Despite the limitations of imaging the lung and thoracic structures, the COVID-19 pandemic and recent advances made this technology an evolving field. The intensive therapy applies these methods with important experience for differential diagnosis and assessment of disease severity or prognosis. Minor modifications of these results make the method beneficial for anesthesia and perioperative medicine. In the present review, the authors accentuate the most important imaging artefacts of lung ultrasonography and the principles of lung ultrasound diagnostic steps. Methods and artefacts of high importance supported by evidence for the assessment of airway management, attuning of intraoperative mechanical ventilation, respiratory disorders during surgery, and postoperative prognosis are articulated. This review intends to focus on evolving subfields in which technological or scientific novelties are expected. Orv Hetil. 2023; 164(22): 864-870.

The effectiveness of disinfection protocols in medical school osteopathic manipulative medicine labs.

CONTEXT: In light of the COVID-19 pandemic, healthcare-associated infections have taken center stage. Healthcare has adjusted workflows to accommodate for more robust disinfecting regiments to help protect the community. This has resulted in the need for medical institutions to reevaluate the current disinfection protocols down to the student level. The osteopathic manipulative medicine (OMM) laboratory provides an optimal avenue for assessing the effectiveness of medical students' ability to clean examination tables. With OMM laboratories having a high level of interaction, adequate disinfection is important for the health and safety of students and teaching faculties. OBJECTIVES: This study will evaluate the effectiveness of the current disinfection protocols in the medical school OMM labs. METHODS: A cross-sectional, nonrandomized study was performed on 20 OMM examination tables utilized for osteopathic training. Tables were chosen based on their close proximity to the podium. Close proximity was utilized as a criteria to increase the probability of utilization by students. The sampled tables were observed to ensure their use by students during class. Initial samples were collected in the morning after disinfection by Environmental Services. Terminal samples were collected after Osteopathic medical students utilized and disinfected the OMM examination tables. Samples were collected from the face-cradle and midtorso regions and analyzed utilizing adenosine triphosphate (ATP) bioluminescence assays with an AccuPoint Advanced HC Reader. This reader provides a digital readout of the quantity of light measured in relative light units (RLUs), which is directly correlated to the amount of ATP present in the sample, providing an estimated pathogen count. For statistical analysis, a Wilcoxon signed-rank test was utilized to find statistical differences in RLUs in samples after initial and terminal disinfection. RESULTS: The face cradle showed a 40 % increase in failure rate in samples after terminal disinfection when samples were compared after initial disinfection. A Wilcoxon signed-rank test revealed an estimated pathogen level for face cradle that was significantly higher after terminal disinfection (median, 4,295 RLUs; range, 2,269-12919 RLUs; n=20) compared to initial disinfection (median, 769 RLUs; range, 29-2,422 RLUs; n=20), z=-3.8, p=0.00008, with a large effect size, d=2.2. The midtorso region showed a 75 % increase in samples after terminal disinfection when samples were compared after initial disinfection. A Wilcoxon signed-rank test revealed that the estimated pathogen levels for midtorso were significantly higher after terminal disinfecting (median, 656 RLUs; range, 112-1,922 RLUs; n=20) compared to initial disinfecting (median, 128 RLUs; range, 1-335 RLUs; n=20), z=-3.9, p=0.00012, with a large effect size, d=1.8. CONCLUSIONS: This study suggests that medical students frequently failed to disinfect high-touch regions on examination tables, such as the midtorso and the face cradle. It is recommended that the current OMM lab disinfection protocol be modified to include the disinfection of high-touch regions in order to reduce the possibility of pathogen transmission. Further research should explore the effectiveness of disinfection protocols in clinical settings such as outpatient offices.

Association between the Nursing Practice Environment and Safety Perception with Patient Safety Culture during COVID-19.

AIMS: In this study, we aimed to identify the relationship between nursing practice environments (NPEs) and safety perceptions with patient safety culture (PSC) during COVID-19. DESIGN: We conducted a quantitative, non-experimental, correlational, and cross-sectional study. We interviewed 211 nurses from Peru using two scales: PES-NWI and HSOPSC. We used the Shapiro-Wilk test and Spearman's coefficient and estimated two regression models. RESULTS: NPE was reported as favorable by 45.5% of the participants, and PSC was reported as neutral by 61.1%. Safety perception, the workplace, and NPE predict PSC. All NPE factors were correlated with PSC. However, safety perception, support of nurses subscale, the nurse manager's ability, and leadership were predictors of PSC. CONCLUSION: To promote a safe work culture, health institutions should foster leadership that prioritizes safety, strengthens managers' abilities, encourages interprofessional collaboration, and considers nurses' feedback for constant improvement.

Factors Affecting Nursing Surveillance Activity among Clinical Nurses.

Nursing surveillance is a defense mechanism that protects patients from adverse events, as it is a systematic process that contributes to nurses' detection of and intervention in dangerous situations. This descriptive cross-sectional study examined the degree of nursing surveillance activity performed by clinical nurses, nurses' perceived importance of nursing surveillance, and their perception of patient safety culture. The study aimed to identify the predictors of nursing surveillance activity. Participants included 205 clinical nurses from two secondary hospitals and two tertiary hospitals in Changwon-si and Cheongju-si, South Korea, who had at least one year of clinical experience. Nursing surveillance activity was high among nurses who were assigned fewer than 1.88 patients, who worked in a tertiary hospital, and those who scored 7.0 or higher in nurses' perceived expertise. Nursing surveillance activity was significantly positively correlated with nurses' perceived importance of nursing surveillance and patient safety culture. A hierarchical multiple regression analysis was performed to identify the predictors of nursing surveillance activity. Nurses' perceived expertise, perceived importance of nursing surveillance, patient safety culture, and type of hospital explained 65.3% of the variance of nursing surveillance activity. This study is significant as it provides an assessment of the extent and key predictors of nursing surveillance activity.

Performance of Early Warning Scoring Systems Regarding Adverse Events of Unanticipated Clinical Deterioration in Complementary and Alternative Medicine Hospitals.

PURPOSE: This study aims to examine the performance of early warning scoring systems regarding adverse events of unanticipated clinical deterioration in complementary and alternative medicine hospitals. METHODS: A medical record review of 500 patients from 5-year patient data in two traditional Korean medicine hospitals was conducted. Unanticipated clinical deterioration events included unexpected in-hospital mortality, cardiac arrest, and unplanned transfers to acute-care conventional medicine hospitals. Scores of the Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), and National Early Warning Score 2 (NEWS2) were calculated. Their performance was evaluated by calculating areas under the receiver-operating characteristic curve for the event occurrence. Multiple logistic regression analyses were performed to determine the factors associated with event occurrence. RESULTS: The incidence of unanticipated clinical deterioration events was 1.1% (225/21101). The area under the curve of MEWS, NEWS, and NEWS2 was .68, .72, and .72 at 24 hours before the events, respectively. NEWS and NEWS2, with almost the same performance, were superior to MEWS (p = .009). After adjusting for other variables, patients at low-medium risk (OR = 3.28; 95% CI = 1.02-10.55) and those at medium and high risk (OR = 25.03; 95% CI = 2.78-225.46) on NEWS2 scores were more likely to experience unanticipated clinical deterioration than those at low risk. Other factors associated with the event occurrence included frailty risk scores, clinical worry scores, primary medical diagnosis, prescribed medicine administration, acupuncture treatment, and clinical department. CONCLUSIONS: The three early warning scores demonstrated moderate-to-fair performance for clinical deterioration events. NEWS2 can be used for early identification of patients at high risk of deterioration in complementary and alternative medicine hospitals. Additionally, patient, care, and system factors need to be considered to improve patient safety.

Effects of safety attitude on factors related to burnout among nurses working at a dedicated infectious disease control hospital during the COVID-19 pandemic.

AIM: Repeated occupational exposure and increased stress and fatigue levels contribute to a high risk of coronavirus disease 2019 (COVID-19) infection among frontline nurses. This study aimed to explore the relationships among teamwork, work environment and resources, work-life balance, stress perception and burnout among nurses working at a dedicated infectious disease control hospital. METHODS: The participants were 389 nurses at a dedicated infectious disease control hospital in Taipei City, Taiwan. This study adopted survey design with a questionnaire using the Safety Attitude Questionnaire. RESULTS: The work-life balance among nurses at the dedicated hospital significantly mediated the effects of teamwork and work environment and resources on burnout. In addition, stress perception had interaction effects on work-life balance and burnout. CONCLUSION: This study's results provide important recommendations for managing teamwork, work environment and resources, work-life balance, stress perception and burnout prevention in nurses to help them better prepare and cope with emergencies. Findings can serve as a reference for developing relevant hospital management policies.

Improving nurses' blood transfusion knowledge and skills.

The World Health Organization (2019) has determined that patient safety is a global public health challenge. In UK clinical areas, policies and procedures are in place for the safe prescribing and delivery of blood and blood product transfusions, yet patient safety incidences continue. Undergraduate nurse education and training may provide the underlying knowledge to practitioners, while postgraduate standalone training sessions support skill development. However, over time, without regular experience, competence will diminish. Nursing students may have little exposure to transfusion practice and COVID-19 may have exacerbated this challenge with a reduction in placement availability. The use of simulation to support theory with follow-up and ongoing drop-in training sessions may help to inform practitioners and improve patient safety in the management and delivery of blood and blood product transfusion.

Green Cross method in a postanaesthesia care unit: a qualitative study of the healthcare professionals' experiences after 3 years, including the COVID-19 pandemic period.

OBJECTIVES: Unsafe medical care causes morbidity and mortality among the hospital patients. In a postanaesthesia care unit (PACU), increasing patient safety is a joint effort between different professions. The Green Cross (GC) method is a user-friendly incident reporting method that incorporates daily safety briefings to support healthcare professionals in their daily patient safety work. Thus, this study aimed to describe healthcare professionals' experiences with the GC method in a PACU setting 3 years after its implementation, including the period of the coronavirus disease 2019 pandemic's three waves. DESIGN: An inductive, descriptive qualitative study was conducted. The data were analysed using qualitative content analysis. SETTING: The study was conducted at a PACU of a university hospital in South-Eastern Norway. PARTICIPANTS: Five semistructured focus group interviews were conducted in March and April 2022. The informants (n=23) were PACU nurses (n=18) and collaborative healthcare professionals (n=5) including physicians, nurses and a pharmacist. RESULTS: The theme 'still active, but in need of revitalisation' was created, describing the healthcare professionals' experiences with the GC method, 3 years post implementation. The following five categories were found: 'continuing to facilitate open communication', 'expressing a desire for more interprofessional collaboration regarding improvements', 'increasing reluctance to report', 'downscaling due to the pandemic' and 'expressing a desire to share more of what went well'. CONCLUSIONS: This study offers information regarding the healthcare professionals' experiences with the GC method in a PACU setting; further, it deepens the understanding of the daily patient safety work using this incident reporting method.

Healthcare workers' experiences of patient safety in the intensive care unit during the COVID-19 pandemic: A multicentre qualitative study.

AIM: To describe healthcare workers' experiences of preconditions and patient safety risks in intensive care units during the COVID-19 pandemic. BACKGROUND: Healthcare workers' ability to adapt to changing conditions is crucial to promote patient safety. During the COVID-19 pandemic, healthcare workers' capacity to maintain safe care was challenged and a more in-depth understanding on frontline experiences of patient safety is needed. DESIGN: A qualitative descriptive design. METHODS: Individual interviews were conducted with 29 healthcare workers (nurses, physicians, nurse assistants and physiotherapists) from three Swedish hospitals directly involved in intensive care of COVID-19 patients. Data were analysed with inductive content analysis. Reporting followed the COREQ checklist. RESULTS: Three categories were identified. Hazardous changes in working conditions describes patient safety challenges associated with the extreme workload with high stress level. Imperative adaptations induced by changed preconditions for patient safety which include descriptions of safety risks following adaptations related to temporary intensive care facilities, handling shortage of medical equipment and deviations from routines. Safety risks triggered by reorganisation of care describe how the diluted skill-mix and team disruptions exposed patients to safety risks, and that safety performance mostly relied on individual healthcare worker's responsibility. CONCLUSIONS: The study suggests that healthcare workers experienced an increase in patient safety risks during the COVID-19 pandemic mainly because the extremely high workload, imperative adaptations, and reorganisation of care regarding skill-mix and teamwork. Patient safety performance relied on the individuals' adaptability and responsibility rather than on system-based safety. RELEVANCE TO CLINICAL PRACTICE: This study provides insights on how healthcare workers' experiences can be used as a source of information for recognition of patient safety risks. To improve detection of safety risks during future crises, guidelines on how to approach safety from a system perspective must include healthcare workers' perceptions on safety risks. PATIENT AND PUBLIC CONTRIBUTION: None in the conceptualisation or design of the study.

Trends in infection-related patient safety incident reporting before and during the COVID-19 pandemic in Korea.

Purpose: The purpose of this study was to analyze the trends and characteristics of infection-related patient safety incident reporting before and during the coronavirus disease 2019 (COVID-19) pandemic in Korea, and to provide basic data for preventing infection-related patient safety incidents and improving their management. Methods: A cross-sectional analysis of secondary national data (Patient Safety Reporting Data) was conducted. In total, 517 infection-related patient safety incidents reported from 2018 to 2021 were analyzed. Changes in the number of reports before and during the COVID-19 pandemic and differences in variables related to infection-related patient safety incidents were analyzed using the chi-square test and independent t-test in SPSS 29.0. Results: This study found that infection-related patient safety incidents decreased during the COVID-19 pandemic compared to before the pandemic. Furthermore, incident-related characteristics, such as the type of healthcare organization, severity of harm, and post-incident actions, changed during the COVID-19 pandemic. Conclusion: The many changes in the infection control system and practices during the COVID-19 pandemic may have contributed to a decrease in the reporting of infection-related patient safety incidents. It is hoped that longitudinal studies on patient safety incidents related to the pandemic and analytical studies on factors influencing patient safety incidents will continue to be conducted to prevent and improve patient safety incidents. [ FROM AUTHOR] Copyright of Journal of Korean Biological Nursing Science is the property of Korean Society of Biological Nursing Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

A Qualitative Analysis of Physician, Staff, and Patient Perspectives During the Discharge Process for Vascular Patients

Objectives: Evidence demonstrates that when hospitals focus on the discharge process patient safety improves and overall costs decline. Hospital discharge requires care coordination of multiple disciplines, often leading to fragmented care, and adverse outcomes after discharge include emergency department visits and hospital readmissions. The Re-Engineered Discharge (RED) process was developed as an evidence-based strategy to improve the hospital discharge. We evaluated perspectives and priorities of physicians, health care workers, and patients involved in the vascular discharge process using RED as a framework. Method(s): A single-center qualitative analysis using a semi-structured focus groups and an interview guide based on the RED process. Focus groups were Zoom platform recorded, transcribed into text files, independently coded, and analyzed with Dedoose qualitative software using a directed content analysis approach. Thematic concepts were created, and comparisons between groups were analyzed by coding frequency. Researchers independently thematically coded each transcript;prior to analysis, all redundancy of codes was resolved;and all team members agreed on text categorization and coding frequency. Result(s): Eight focus groups with 38 participants were performed. Participants included: physicians (n = 13), nursing and ancillary staff (n = 19), and patients/caregivers (n = 6). Transcript analyses revealed facilitators and barriers to discharge. Overarching themes identified from the qualitative analysis frequencies are displayed by stakeholder role (Fig 1). Themes identified with the greatest coding frequencies included helpfulness of discharge instructions, patient health literacy, patient medical complexity, poor interdisciplinary team communication, time constraints during discharge, technology literacy of patients, barriers to obtaining medications for patients, barriers to organizing outpatient services for health care workers, barriers for patients to obtain help after discharge, and the impact of COVID-19. Conclusion(s): These findings identify the need to strengthen efforts to overcome stakeholder barriers to improve patient safety at the interface of the hospital to create a well-organized discharge. Physicians were most concerned with low patient health literacy, patient understanding of discharge instructions, organizing outpatient services, and overall patient medical complexity hindering a smooth discharge. Health care staff identified time constraints, obtaining medications and, and inter-team communication as their greatest obstacles to an organized discharge. Patients found the complexity and amount of discharge instructions, the impact of COVID-19 on support systems, and technology utilization after discharge most challenging. Modifications to address individual stakeholder barriers within the discharge process are needed to develop a national standardized discharge specific for vascular surgery patients to improve patient safety and satisfaction. [Formula presented]Copyright © 2023

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

[...]many sponsors have implemented alternative ways to conduct trials or components of them, incorporating remote and virtual activities, which aim to bring studies directly to patients via a range of technologies. Every clinical investigation begins with the development of a protocol that describes h.ow a clinical trial will be conducted-encompassing the objective(s), design, methodology, statistical considerations, and organization of the study-and ensures the safety of the trial subjects and integrity of the data collected. [...]of the pandemic, we will see more hybrid trials that combine site and remote patient visits. In forcing the research community to be more open to using different tools to ensure vital research continues, the pandemic is driving the beginning of a new era of patient and site engagement-one in which a more proactive and efficient approach ensures the lines of communication remain open and data is collected appropriately and with greater speed.

Overcoming Vaccine Development Challenges

According to recent market research, the vaccines market is expected to grow at a compound annual rate of 14.7% for the forecast period of 2020-2026 (1), the growth of which has been accelerated by the recent COVID-19 pandemic. Durability of glass vials at very low temperatures and permeability of plastic vials has complicated the packaging decisions as well." Since the beginning of the pandemic, the bio/pharma industry has been under pressure to produce stable formulations for effective vaccines in accelerated timescales, Blouet asserts. [...]the drive for a COVID-19 vaccine has occurred during a period of increased basic scientific understanding, such as in genomics and structural biology, supporting a new wave of vaccine development and production, she says. According to Phadnis, in addition to single-use technologies, automation for high throughput and robust analytical assays are necessary for rapid turnover during development and manufacturing of vaccines.

Can We Teach an Old Drug New Tricks?

The French study that piqued interest in using hydroxychloroquine to treat COVID-19, by way of example, was not designed to the expected industry standard and, so despite being published (2), is now undergoing an additional independent peer review (3). Furthermore, studies demonstrating a contrary opinion-that chloroquine and hydroxychloroquine do not have a suitable risk-to-benefit ratio in terms of COVID-19 treatment-also have limitations. Bill & Melinda Gates Foundation, "COVID-19 Therapeutics Accelerator Awards $20 Million in Initial Grants to Fund Clinical Trials," gatesfoundation.org, Press Release, 30 March 2020.

Risk of 12-month mortality following a severe inpatient hypoglycaemic event: A single centre retrospective study from the North-West of England

Aims: At our Trust, all severe inpatient hypoglycaemic episodes in individuals with diabetes (defined as a hypoglycaemic episode requiring injectable treatment) are reported to NaDIA-Harms (National Diabetes Inpatient Audit). We conducted a detailed review of the care of all these events to improve patient safety. In this study, we assessed the risk of 12-month mortality following an episode of severe inpatient hypoglycaemia. Method(s): Reportable NaDIA harms of patients admitted during the period 2018-2022 were recorded into a dataset. Applicable patient records were reviewed at 12 months following the event to see how many patients were deceased and details of comorbidities at the time of the severe hypoglycaemic episode were collected. Result(s): To date, of 107 inpatients who experienced a severe hypoglycaemic episode 55% were deceased within 12 months. In patients admitted during the peak of the Covid-19 pandemic recorded as year April 2020/March 2021, 80% of patients who had a NaDIA hypoglycaemic event died within 12 months. Conclusion(s): Mortality rate following an episode of inpatient hypoglycaemia appears to be several-fold higher than previous reported rates of 4.45%-22.1% for community-dwelling individuals who experience a severe hypoglycaemic event. This maybe partially explained by the increased frailty, polypharmacy and multimorbidity among this cohort, but there is evidence linking hypoglycaemia with cardiovascular mortality. Although no causality between severe inpatient hypoglycaemia and death can be inferred from this study because of the observational nature, it does highlight the importance preventing inpatient episodes of hypoglycaemia through effective monitoring and proactive treatment modification.

Moving Clinical Operations Forward During Pandemic

In the short and long term, sponsors should think through: * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions: