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Protocol Review
Our team conducts a meticulous examination of the Protocol to ensure its compliance with the essential elements outlined in the Good Clinical Practice (GCP) guidelines. This comprehensive assessment involves a thorough review of all sections to ensure coherence and identify any discrepancies. By conducting a protocol review, we aim to enhance the quality and integrity of the study design.
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Preparation of Protocol Synopsis
We provide a comprehensive and concise Protocol Synopsis that captures the primary objective and relevant details of the study. This synopsis serves as a condensed version of the protocol, allowing stakeholders to grasp the essential aspects of the research quickly. Our goal is to create a clear and concise summary that facilitates a better understanding of the study's purpose and methods.
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Sample Size calculation
We4 Clinical Research offers support to the Sponsor in determining the appropriate sample size for the study. Through the application of statistical methodologies and considering relevant factors such as effect size, power, and desired level of significance, we assist in determining the optimal number of participants needed to achieve meaningful and statistically significant results. Our expertise in sample size calculation ensures that studies are adequately powered to draw accurate conclusions.
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Statistical Analysis
Our experienced team at We4 Clinical Research collaborates closely with the Sponsor to plan and execute robust statistical tests and analyses. We employ state-of-the-art statistical methods and software to analyse and interpret the collected data. By applying appropriate statistical techniques, we aim to derive meaningful insights, identify patterns, and draw valid conclusions from the research findings.
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Budgeting
At We4 Clinical Research, we provide assistance in allocating financial resources necessary for conducting a trial. This includes calculating the Patients Fee, which involves estimating the costs associated with patient recruitment, retention, and compensation. Additionally, we assist in negotiating the Clinical Trial Agreement (CTA) to ensure that the financial aspects are adequately addressed and aligned with the trial requirements. Our goal is to help optimize the budgeting process and ensure efficient allocation of resources while maintaining compliance with regulatory and ethical considerations.
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Sites Feasibility and Sites Selection
We4 Clinical Research conducts comprehensive feasibility assessments by drafting and distributing Feasibility Questionnaires to potential sites. Based on the responses received, we assist the Sponsor in selecting the most appropriate sites to carry out the trial. We offer support to the Sponsor in this activity ensuring that sites meet the requirements of the study and align with the characteristics desired by the Sponsor.
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Contract Research Organization (CRO) selection
We4 Clinical Research can assist the Sponsor in evaluating and selecting external local CROs that will best meet the needs of the trial, ensuring that their capabilities and experience are compliant with study requirements.
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Selection of laboratories and Corelab
We4 Clinical Research can assist the Sponsor in the selection of laboratories for the analysis of study bio-samples, images, and other elements. Through feasibility assessments, we ensure that the selected laboratories have the necessary capabilities, equipment, and expertise to perform the required analyses accurately and efficiently.
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Stipulation of Insurance
We4 Clinical Research assists the Sponsor in the stipulation of an appropriate insurance policy based on the characteristics of the study. Our services include contacting insurance brokers, soliciting quotations, compiling and distributing the necessary documentation, and monitoring insurance updates throughout the study. We aim to ensure that the study is adequately covered by insurance and that potential risks are mitigated.
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Data Management Plan Design
We collaborate with the Study Sponsor and Principal Investigator to develop a comprehensive data management plan. This plan outlines procedures and guidelines to ensure effective data management throughout the study trial. Our expertise in data management helps establish standardized processes for data collection, storage, validation, and analysis, promoting data integrity and quality.
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Case Report Form (CRF) Design
We4 Clinical Research can design a Case Report Form tailored to the specific requirements of the study. We work closely with the Sponsor and study team to develop a comprehensive and user-friendly CRF. Additionally, we plan and implement edit checks to ensure data accuracy and completeness before the CRF's online implementation.
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eCRF design
We strive to seamlessly transition the Case Report Form (CRF) into an electronic CRF (eCRF) that closely mirrors its paper counterpart. Our focus is on creating a simplified and user-friendly eCRF interface to enhance data collection efficiency and accuracy.
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Randomization List generation
For randomized studies, We4 Clinical Research generates customized Randomization Lists. We assist in selecting appropriate stratification factors and block sizes to ensure the randomization process is robust and unbiased. Our aim is to facilitate the random assignment of participants to study arms, maintaining the study's integrity.
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Data Safety Monitoring Board (DSMB) or Clinical Events Committee (CEC)
We4 Clinical Research provides support in drafting Data Safety Monitoring Board (DSMB) or Clinical Events Committee (CEC) charters. We also organize and facilitate their meetings on behalf of the Sponsor. Our involvement ensures that the study has appropriate oversight and monitoring to safeguard participant safety and study integrity.
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Study website and social media channels
We4 Clinical Research enhances the visibility of your study by setting up a dedicated study website and promoting the trial through popular social media channels. We ensure proper engagement with potential participants and study stakeholders, facilitating quick updates and information dissemination. Our goal is to maximize recruitment and retention for the study through effective online presence and communication channels.
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Statistical Analysis Plan (SAP)
We4 Clinical Research develops a comprehensive Statistical Analysis Plan (SAP) that outlines the appropriate methods and analyses for the study data. This plan ensures that the statistical analysis is conducted in a rigorous and valid manner, leading to accurate and meaningful interpretation of the study results.
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Monitoring Plan
We4 Clinical Research offers guidance in determining the most suitable monitoring strategy based on the Sponsor's requirements. We develop Monitoring Plans that define the frequency and mode of conduct for monitoring visits. Our goal is to ensure effective oversight of study activities, data quality, and adherence to protocol and regulatory requirements.
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Quality Plan
We4 Clinical Research assists in defining a Quality Plan to ensure the validity and reliability of the clinical trial results. This plan encompasses strategies and procedures for quality control and quality assurance throughout the study. By implementing robust quality management practices, we aim to maintain the integrity and credibility of the study outcomes.
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Kick-Off Meeting and Investigators’ Meetings
We4 Clinical Research organizes kick-off meetings and Investigators' meetings. These meetings serve as crucial platforms for effective communication, collaboration, and alignment among study stakeholders. We provide support in planning and executing these meetings, including agenda development, presentation creation, and guest invitations.
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Registration of the study on clinicaltrials.gov
We4 Clinical Research takes responsibility for registering the study on ClinicalTrials.gov on behalf of the Sponsor. This ensures that the study becomes publicly accessible to the scientific community, increasing visibility and facilitating transparency. We handle the registration process, including the submission of relevant study information and updates as required.