Clinical
Our goal is to help you develop a comprehensive and well-organized clinical operation that meets the standards of good clinical practice and enables you to conduct your study effectively.
Our team will help you design your protocol, keeping the end in mind. We ensure proper primary and secondary endpoints are chosen, we review the target population and determine the possible recruitment challenges, keeping FDA recommendations in mind.
Let us handle the details and give you the best chance at success.
Protocol Development
Our Clinical Protocol Development service includes the following: Research question definition: We help you clearly define the research question that your study is intended to answer, and identify the primary and secondary objectives of the study. Study design: We work with you to design your study in a way that addresses the research question and meets the objectives of the study. This includes selecting the study population, defining the inclusion and exclusion criteria, and determining the sample size. Protocol development: We write the protocol, including the background and rationale for the study, the design and methods of the study, and the criteria for evaluating the results. Review and revision: We review the protocol for completeness and compliance with the standards of good clinical practice, and provide feedback and suggestions for improvement. Approval support: We submit the protocol to the appropriate regulatory authorities and/or institutional review board (IRB) on your behalf, and provide support throughout the approval process. Implementation support: We provide support to ensure that the protocol is followed during the conduct of the study, and that the study is conducted in a consistent and ethical manner. Our goal is to help you develop a comprehensive and well-organized clinical protocol that meets the standards of good clinical practice and enables you to conduct your study effectively. Let us handle the details and give you the best chance at success.
SOW Reviews
Our SOW Review for Clinical Operations service includes the following: Thorough review: We read the SOW thoroughly and ensure that we understand the scope, deliverables, and terms of the project or engagement as it relates to the clinical trial. Completeness assessment: We confirm that the SOW is complete, including all necessary information related to the conduct of the clinical trial, such as details on the study design, patient population, data collection procedures, and reporting requirements. Accuracy verification: We verify that the information in the SOW is correct and consistent with the terms of the engagement, and that it aligns with the protocol and other study documents. Compliance check: We review the SOW to ensure that it is compliant with relevant regulations and standards, such as those related to privacy, security, and intellectual property. Feedback and suggestions: We provide feedback and suggestions for improvement to the client or service provider, if necessary. Our goal is to ensure that the SOW for your clinical trial is complete, accurate, and compliant with all relevant regulations and standards. Let us handle the details and give you the peace of mind that comes with knowing your SOW is thorough and reliable.
Protocol Amendment
Our Clinical Protocol Amendment service includes the following: Need assessment: We help you determine the reason for the amendment and how it will impact the study. Amendment preparation: We make the necessary changes to the protocol and prepare a document outlining the proposed amendment. Review and revision: We review the amendment for completeness and compliance with the standards of good clinical practice, and provide feedback and suggestions for improvement. Submission: We submit the amendment to the appropriate regulatory authorities and/or institutional review board (IRB) on your behalf. Implementation support: If the amendment is approved, we provide support to ensure that the changes to the protocol are implemented correctly and that all relevant documents and systems are updated to reflect the amendment. Our goal is to help you make necessary changes to your clinical protocol in a timely and efficient manner, while ensuring that the amendment meets the standards of good clinical practice. Let us handle the details and give you the support you need to move forward with your study.
Vendor Management
Our Vendor Management for Clinical Operations service includes the following: Vendor identification: We help you determine the goods or services that are necessary for the conduct of your trial, and identify potential vendors that can provide these. Vendor evaluation: We evaluate the potential vendors to determine which ones are the best fit for the needs of your trial, considering factors such as price, quality, reliability, and reputation. Term negotiation: We negotiate the terms and conditions of the relationship with the chosen vendors, including issues such as pricing, delivery, and warranties. Performance monitoring: We monitor the performance of the vendors to ensure that they are meeting the requirements of your trial. This includes tracking key performance indicators (KPIs) such as on-time delivery, product quality, and customer satisfaction. Risk management: We identify and manage any risks associated with working with the vendors, including financial, legal, and regulatory risks. Our goal is to help you effectively manage your vendor relationships and ensure that you have the goods and services you need to conduct your trial successfully. Let us handle the details and give you the support you need to focus on the important work of your trial.
Contract Development
Patient Recruitment Strategy Development
Our consultancy firm offers contract development services for clinical operations. We have a team of experienced professionals who specialize in managing contracts related to clinical research studies. Our services include negotiating terms with sponsors, CROs, and other partners, tracking compliance with contract terms, and working with legal teams to draft and review contracts. We also provide budgeting and financial projection services to help clients plan and manage the costs associated with their clinical studies. Our goal is to ensure that all parties involved in a clinical trial adhere to the terms of their contracts, so that the study can be conducted smoothly and efficiently.
Our consultancy firm offers patient recruitment strategy development services for clinical operations. We have a team of experts who can help you plan and implement effective tactics for enrolling sufficient numbers of appropriate participants in your clinical study. Our services include identifying and reaching out to potential participants, explaining the study and obtaining informed consent, and ensuring that participants meet the inclusion and exclusion criteria for the study. We consider a variety of factors in developing patient recruitment strategies, such as the target patient population, the availability of potential participants, the competition for participants, and the resources available for recruitment. We use a variety of tactics to reach potential participants, such as advertising, collaborating with advocacy groups and healthcare providers, and using social media and other online tools. Our goal is to help you conduct patient recruitment efforts ethically and in compliance with all relevant regulations and guidelines.
Investigator Brochure Development
Our consultancy firm offers investigator brochure development services for clinical operations. We have a team of experts who can help you create a comprehensive and accurate document that provides information about your clinical trial to investigators and other healthcare professionals. Our services include gathering and organizing information about the trial, working with subject matter experts to ensure the accuracy and completeness of the document, and ensuring compliance with all relevant regulations and guidelines. Our goal is to help you create an investigator brochure that effectively communicates the details of your clinical trial to potential investigators and other stakeholders.
ICF & Assessment Coordination and Development
CTN Development
Our consultancy firm offers ICF development and assessment coordination and development services for clinical operations. We have a team of experts who can help you plan and implement these important processes for your clinical trial. Our ICF development services include creating clear and easy-to-understand informed consent forms that protect the rights and welfare of clinical trial participants. Our assessment coordination and development services include developing and administering study assessments, collecting and managing data, and analyzing and reporting on the results of the study. Our goal is to help you ensure the success of your clinical trial by planning and implementing these processes in a professional and effective manner.
Our consultancy firm offers CTN development services for clinical operations. We have a team of experts who can help you establish and organize a clinical trial network. Our services include identifying and recruiting researchers and healthcare professionals to participate in the network, establishing the infrastructure and resources needed to support the network, and developing protocols and procedures for conducting clinical trials. Our goal is to help you create a clinical trial network that is efficient and effective in conducting clinical trials.
Phase I Protocol Development
Our consultancy firm offers Phase I protocol development services for clinical operations. We have a team of experts who can help you plan and develop a protocol for your Phase I clinical trial. Our services include working with subject matter experts to design the trial and develop the necessary study documents, such as the informed consent form and case report forms. We ensure that the protocol is carefully planned and clearly written, so that the trial can be conducted smoothly and successfully. Our goal is to help you conduct a Phase I clinical trial that is ethical, efficient, and compliant with all relevant regulations and guidelines.
Phase II & Phase III Protocol Development
Our consultancy firm offers Phase II and Phase III protocol development services for clinical operations. We have a team of experts who can help you plan and develop protocols for these later stage clinical trials. Our services include working with subject matter experts to design the trial and develop the necessary study documents, such as the informed consent form and case report forms. We ensure that the protocols are carefully planned and clearly written, so that the trials can be conducted smoothly and successfully. Our goal is to help you conduct Phase II and Phase III clinical trials that are ethical, efficient, and compliant with all relevant regulations and guidelines.
Investigatory Procedure Label Development
Our consultancy firm offers investigatory procedure label development services for clinical operations. We have a team of experts who can help you create a label that meets the requirements for identifying a device or product being used for investigational purposes in a clinical trial. Our services include working with regulatory affairs professionals to ensure that the label meets all relevant regulations and guidelines, and developing the design and layout of the label to ensure that it is clear and easy to understand. Our goal is to help you create an investigatory procedure label that is compliant with all relevant regulations and guidelines and that effectively identifies devices and products being used in clinical trials.
