InSiGHt Health Clinical Ltd is a Contract Research Organization (CRO) dedicated to delivering exceptional clinical services and research. Our mission is to support emerging to mid-sized companies by providing comprehensive solutions throughout the clinical operations process, ensuring the highest standards of quality, integrity, and service excellence.
Whether you are navigating the complexities of product registration, managing clinical trials, or seeking expert project management, we are here to support you every step of the way. Together, we can achieve excellence in clinical operations and bring your innovative products to market successfully.
At InSiGHt Health Clinical Ltd, we offer a robust suite of Site Management Services designed to ensure the smooth execution of your clinical trials
At InSiGHt Health Clinical Ltd, we offer a robust suite of Site Management Services designed to ensure the smooth execution of your clinical trials. Our services encompass every phase of site management, from identification and feasibility studies to routine monitoring and closeout visits, all tailored to meet the unique needs of emerging to mid-sized companies. Our dedicated team of experts ensures that each step of the process adheres to the highest standards of quality, integrity, and service excellence.
Site Identification and Feasibility Studies
Identifying and selecting the right sites is crucial for the success of any clinical trial. Our team conducts thorough feasibility studies to assess potential sites, evaluating factors such as patient demographics, site infrastructure, and previous trial performance. This ensures that we select the most suitable sites that align with your trial’s objectives and timeline.
Pre-study Visits
Before the initiation of a clinical trial, our pre-study visits serve to verify the readiness and capability of selected sites. During these visits, we assess site facilities, review staff qualifications, and ensure that all necessary resources are in place. This meticulous preparation lays the groundwork for a successful trial.
Initiation Visits
Initiation visits mark the official start of your clinical trial at each site. Our experts provide comprehensive training to site staff, ensuring they are well-versed in the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. We also review all study materials and ensure that site staff are equipped to handle trial-related activities efficiently.
Routine Monitoring Visits
Regular monitoring visits are essential to maintaining the integrity and progress of your clinical trial. Our monitoring team conducts periodic site visits to oversee trial activities, verify data accuracy, ensure compliance with protocols, and address any issues promptly. This continuous oversight helps to maintain high standards of quality and reliability throughout the study.
Closeout Visits
Upon completion of the clinical trial, our closeout visits ensure that all study activities are appropriately concluded. During these visits, we conduct a thorough review of study documentation, resolve any outstanding issues, and ensure that all regulatory requirements are met. This final step ensures a smooth and compliant closure of the trial site.
At InSiGHt Health Clinical Ltd, our comprehensive Site Management Services are designed to support your clinical trials from start to finish, providing you with the confidence and assurance that your trial is in capable hands. With our commitment to excellence, we help you achieve your clinical research goals with precision and efficiency.
Our holistic approach encompasses support for site and sponsor personnel, meticulous timeline management, regulatory submissions, quality assurance, and overall project coordination
InSiGHt Health Clinical Ltd is committed to providing top-tier Project Management Services that ensure the seamless execution and oversight of your clinical trials. Our holistic approach encompasses support for site and sponsor personnel, meticulous timeline management, regulatory submissions, quality assurance, and overall project coordination. We tailor our services to meet the distinct needs of emerging to mid-sized companies, guaranteeing excellence and integrity throughout the clinical trial process.
Support to Site and Sponsor Personnel
We offer continuous support to both site and sponsor personnel, acting as a reliable point of contact and ensuring effective communication and collaboration. Our experienced team provides guidance and assistance, helping to address any challenges and facilitating smooth trial operations.
Development and Maintenance of Timelines
Our experts develop detailed project timelines that outline key milestones and deliverables. We continuously monitor and adjust these timelines to ensure that your clinical trial progresses efficiently and stays on schedule, mitigating any potential delays.
Ethics and IRB Submissions and Follow-Up
Navigating the regulatory landscape is crucial for the success of clinical trials. We manage all aspects of ethics and Institutional Review Board (IRB) submissions, from initial application to follow-up communications, ensuring compliance with all regulatory requirements and expediting approvals.
Quality Assurance and Compliance
Maintaining the highest standards of quality and compliance is at the core of our services. We implement rigorous quality assurance processes and regular audits to ensure that all trial activities adhere to Good Clinical Practice (GCP) guidelines and regulatory standards, minimizing risks and ensuring data integrity.
Preparation of Study SOPs/Manuals/Guides
Clear and comprehensive documentation is essential for the consistent execution of clinical trials. We develop and maintain Standard Operating Procedures (SOPs), study manuals, and guides tailored to your specific trial needs, providing clear instructions and protocols for all involved parties.
Development of Project Management Plans
We create detailed project management plans that cover all aspects of clinical trial management, including clinical monitoring, communication strategies, and training programs. These plans ensure that all team members are aligned and that the trial runs smoothly from start to finish.
Oversight of Scope of Work and Budget
Effective financial management is critical for the success of clinical trials. We oversee the scope of work and budget, providing early identification of potential change orders and conducting monthly forecasting. This proactive approach helps to manage costs and avoid budget overruns.
Overall Project Coordination and Management
Our comprehensive project coordination and management services ensure that all trial activities are seamlessly integrated and executed. We provide end-to-end oversight, from planning and initiation to execution and closeout, ensuring that your clinical trial meets its objectives efficiently and effectively.
At InSiGHt Health Clinical Ltd, our Project Management Services are designed to provide you with the confidence and assurance that your clinical trial is managed with precision, quality, and compliance. Trust us to support your research goals and drive your projects to successful completion.
Our expert team manages all aspects of data handling, from initial site identification and feasibility studies to meticulous data entry, CRF review, query management, and source data verification.
At InSiGHt Health Clinical Ltd, we provide comprehensive Data Management Services designed to ensure the accuracy, integrity, and reliability of your clinical trial data. Our expert team manages all aspects of data handling, from initial site identification and feasibility studies to meticulous data entry, CRF review, query management, and source data verification. Our services are tailored to meet the needs of emerging to mid-sized companies, ensuring high-quality data management throughout the clinical trial process.
Site Identification and Feasibility Studies
Effective data management begins with selecting the right sites. Our team conducts thorough site identification and feasibility studies to evaluate potential sites based on their data handling capabilities, patient population, and infrastructure. This ensures that we choose sites that are well-equipped to meet your trial’s data management requirements and objectives.
Data Entry
Accurate data entry is crucial for the success of any clinical trial. Our dedicated data entry specialists ensure that all data is entered correctly and efficiently into the clinical trial database. We employ rigorous quality control measures to minimize errors and maintain the integrity of the data.
CRF Review
Our Clinical Research Form (CRF) review process ensures that all data collected is complete, accurate, and consistent with the study protocol. Our team performs detailed reviews of CRFs to identify and resolve any discrepancies or missing information, ensuring that the data is reliable and ready for analysis.
Query Management
Effective query management is essential for maintaining data quality and addressing any issues promptly. Our team oversees the entire query management process, including:
Source Data Verification
Ensuring the accuracy and reliability of clinical trial data requires meticulous source data verification (SDV). Our SDV process involves:
With InSiGHt Health Clinical Ltd, you can trust that your clinical trial data will be managed with precision, quality, and compliance. Partner with us to ensure the success of your clinical research through robust and reliable data management services.
Our comprehensive Laboratory & Clinical Sites Evaluation service is designed to identify, assess, and manage the best sites for your clinical trials.
InSiGHt Health Clinical Ltd offers a comprehensive Laboratory & Clinical Sites Evaluation service designed to identify, assess, and manage the best sites for your clinical trials. Our detailed and systematic approach ensures that each site is optimally selected, set up, and maintained to meet the highest standards of quality and compliance. This service is essential for emerging to mid-sized companies aiming to execute successful clinical trials with reliable and high-performing sites.
Site Identification and Set Up Design and Planning
Selecting the right sites is a critical step in ensuring the success of your clinical trials. Our team provides thorough site identification and set-up design and planning services, which include:
Site Assessment and Management
Once sites are identified, our focus shifts to thorough assessment and ongoing management to maintain high standards and operational efficiency. Our services in this area include:
Site Audits
Ensuring compliance and quality is paramount in clinical trials. Our site audit services provide a rigorous review of site operations, including:
Partner with InSiGHt Health Clinical Ltd for your Laboratory & Clinical Sites Evaluation needs, and ensure your clinical trials are executed with precision, quality, and reliability. Our dedicated team is here to support you every step of the way, from site selection to successful trial completion.
We offer comprehensive Regulatory and Market Entry Services to facilitate the successful registration and launch of medical products and devices.
At InSiGHt Health Clinical Ltd, we offer comprehensive Regulatory and Market Entry Services to facilitate the successful registration and launch of medical products and devices. Our expert team is dedicated to navigating the complex regulatory landscape and ensuring your products meet all necessary requirements for market entry. From initial submissions to post-approval support, we provide end-to-end solutions tailored to the unique needs of emerging to mid-sized companies.
Regulatory Submissions and Follow-Up
Navigating regulatory requirements is a critical step in bringing medical products and devices to market. Our team of regulatory experts manages the entire submission process, ensuring that all necessary documentation is prepared and submitted accurately and timely. We handle:
Our thorough and proactive approach ensures that your regulatory submissions are handled efficiently, minimizing delays and facilitating a smooth approval process.
Medical Products and Devices Registration and Market Entry
Entering new markets requires careful planning and execution. We provide comprehensive support to ensure your medical products and devices are registered and ready for market entry. Our services include:
Our team stays up-to-date with the latest regulatory changes and market trends, providing you with strategic insights and guidance to navigate the complexities of product registration and market entry.
Why Choose InSiGHt Health Clinical Ltd?
With InSiGHt Health Clinical Ltd, you can trust that your medical products and devices will navigate the regulatory landscape smoothly and reach the market efficiently. Partner with us to ensure the successful registration and launch of your products, driving your business forward with confidence and success.
At InSiGHt Health Clinical Ltd, we offer a robust suite of Site Management Services designed to ensure the smooth execution of your clinical trials
At InSiGHt Health Clinical Ltd, we offer a robust suite of Site Management Services designed to ensure the smooth execution of your clinical trials. Our services encompass every phase of site management, from identification and feasibility studies to routine monitoring and closeout visits, all tailored to meet the unique needs of emerging to mid-sized companies. Our dedicated team of experts ensures that each step of the process adheres to the highest standards of quality, integrity, and service excellence.
Site Identification and Feasibility Studies
Identifying and selecting the right sites is crucial for the success of any clinical trial. Our team conducts thorough feasibility studies to assess potential sites, evaluating factors such as patient demographics, site infrastructure, and previous trial performance. This ensures that we select the most suitable sites that align with your trial’s objectives and timeline.
Pre-study Visits
Before the initiation of a clinical trial, our pre-study visits serve to verify the readiness and capability of selected sites. During these visits, we assess site facilities, review staff qualifications, and ensure that all necessary resources are in place. This meticulous preparation lays the groundwork for a successful trial.
Initiation Visits
Initiation visits mark the official start of your clinical trial at each site. Our experts provide comprehensive training to site staff, ensuring they are well-versed in the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. We also review all study materials and ensure that site staff are equipped to handle trial-related activities efficiently.
Routine Monitoring Visits
Regular monitoring visits are essential to maintaining the integrity and progress of your clinical trial. Our monitoring team conducts periodic site visits to oversee trial activities, verify data accuracy, ensure compliance with protocols, and address any issues promptly. This continuous oversight helps to maintain high standards of quality and reliability throughout the study.
Closeout Visits
Upon completion of the clinical trial, our closeout visits ensure that all study activities are appropriately concluded. During these visits, we conduct a thorough review of study documentation, resolve any outstanding issues, and ensure that all regulatory requirements are met. This final step ensures a smooth and compliant closure of the trial site.
At InSiGHt Health Clinical Ltd, our comprehensive Site Management Services are designed to support your clinical trials from start to finish, providing you with the confidence and assurance that your trial is in capable hands. With our commitment to excellence, we help you achieve your clinical research goals with precision and efficiency.
Our holistic approach encompasses support for site and sponsor personnel, meticulous timeline management, regulatory submissions, quality assurance, and overall project coordination
InSiGHt Health Clinical Ltd is committed to providing top-tier Project Management Services that ensure the seamless execution and oversight of your clinical trials. Our holistic approach encompasses support for site and sponsor personnel, meticulous timeline management, regulatory submissions, quality assurance, and overall project coordination. We tailor our services to meet the distinct needs of emerging to mid-sized companies, guaranteeing excellence and integrity throughout the clinical trial process.
Support to Site and Sponsor Personnel
We offer continuous support to both site and sponsor personnel, acting as a reliable point of contact and ensuring effective communication and collaboration. Our experienced team provides guidance and assistance, helping to address any challenges and facilitating smooth trial operations.
Development and Maintenance of Timelines
Our experts develop detailed project timelines that outline key milestones and deliverables. We continuously monitor and adjust these timelines to ensure that your clinical trial progresses efficiently and stays on schedule, mitigating any potential delays.
Ethics and IRB Submissions and Follow-Up
Navigating the regulatory landscape is crucial for the success of clinical trials. We manage all aspects of ethics and Institutional Review Board (IRB) submissions, from initial application to follow-up communications, ensuring compliance with all regulatory requirements and expediting approvals.
Quality Assurance and Compliance
Maintaining the highest standards of quality and compliance is at the core of our services. We implement rigorous quality assurance processes and regular audits to ensure that all trial activities adhere to Good Clinical Practice (GCP) guidelines and regulatory standards, minimizing risks and ensuring data integrity.
Preparation of Study SOPs/Manuals/Guides
Clear and comprehensive documentation is essential for the consistent execution of clinical trials. We develop and maintain Standard Operating Procedures (SOPs), study manuals, and guides tailored to your specific trial needs, providing clear instructions and protocols for all involved parties.
Development of Project Management Plans
We create detailed project management plans that cover all aspects of clinical trial management, including clinical monitoring, communication strategies, and training programs. These plans ensure that all team members are aligned and that the trial runs smoothly from start to finish.
Oversight of Scope of Work and Budget
Effective financial management is critical for the success of clinical trials. We oversee the scope of work and budget, providing early identification of potential change orders and conducting monthly forecasting. This proactive approach helps to manage costs and avoid budget overruns.
Overall Project Coordination and Management
Our comprehensive project coordination and management services ensure that all trial activities are seamlessly integrated and executed. We provide end-to-end oversight, from planning and initiation to execution and closeout, ensuring that your clinical trial meets its objectives efficiently and effectively.
At InSiGHt Health Clinical Ltd, our Project Management Services are designed to provide you with the confidence and assurance that your clinical trial is managed with precision, quality, and compliance. Trust us to support your research goals and drive your projects to successful completion.
Our expert team manages all aspects of data handling, from initial site identification and feasibility studies to meticulous data entry, CRF review, query management, and source data verification.
At InSiGHt Health Clinical Ltd, we provide comprehensive Data Management Services designed to ensure the accuracy, integrity, and reliability of your clinical trial data. Our expert team manages all aspects of data handling, from initial site identification and feasibility studies to meticulous data entry, CRF review, query management, and source data verification. Our services are tailored to meet the needs of emerging to mid-sized companies, ensuring high-quality data management throughout the clinical trial process.
Site Identification and Feasibility Studies
Effective data management begins with selecting the right sites. Our team conducts thorough site identification and feasibility studies to evaluate potential sites based on their data handling capabilities, patient population, and infrastructure. This ensures that we choose sites that are well-equipped to meet your trial’s data management requirements and objectives.
Data Entry
Accurate data entry is crucial for the success of any clinical trial. Our dedicated data entry specialists ensure that all data is entered correctly and efficiently into the clinical trial database. We employ rigorous quality control measures to minimize errors and maintain the integrity of the data.
CRF Review
Our Clinical Research Form (CRF) review process ensures that all data collected is complete, accurate, and consistent with the study protocol. Our team performs detailed reviews of CRFs to identify and resolve any discrepancies or missing information, ensuring that the data is reliable and ready for analysis.
Query Management
Effective query management is essential for maintaining data quality and addressing any issues promptly. Our team oversees the entire query management process, including:
Source Data Verification
Ensuring the accuracy and reliability of clinical trial data requires meticulous source data verification (SDV). Our SDV process involves:
With InSiGHt Health Clinical Ltd, you can trust that your clinical trial data will be managed with precision, quality, and compliance. Partner with us to ensure the success of your clinical research through robust and reliable data management services.
Our comprehensive Laboratory & Clinical Sites Evaluation service is designed to identify, assess, and manage the best sites for your clinical trials.
InSiGHt Health Clinical Ltd offers a comprehensive Laboratory & Clinical Sites Evaluation service designed to identify, assess, and manage the best sites for your clinical trials. Our detailed and systematic approach ensures that each site is optimally selected, set up, and maintained to meet the highest standards of quality and compliance. This service is essential for emerging to mid-sized companies aiming to execute successful clinical trials with reliable and high-performing sites.
Site Identification and Set Up Design and Planning
Selecting the right sites is a critical step in ensuring the success of your clinical trials. Our team provides thorough site identification and set-up design and planning services, which include:
Site Assessment and Management
Once sites are identified, our focus shifts to thorough assessment and ongoing management to maintain high standards and operational efficiency. Our services in this area include:
Site Audits
Ensuring compliance and quality is paramount in clinical trials. Our site audit services provide a rigorous review of site operations, including:
Partner with InSiGHt Health Clinical Ltd for your Laboratory & Clinical Sites Evaluation needs, and ensure your clinical trials are executed with precision, quality, and reliability. Our dedicated team is here to support you every step of the way, from site selection to successful trial completion.
We offer comprehensive Regulatory and Market Entry Services to facilitate the successful registration and launch of medical products and devices.
At InSiGHt Health Clinical Ltd, we offer comprehensive Regulatory and Market Entry Services to facilitate the successful registration and launch of medical products and devices. Our expert team is dedicated to navigating the complex regulatory landscape and ensuring your products meet all necessary requirements for market entry. From initial submissions to post-approval support, we provide end-to-end solutions tailored to the unique needs of emerging to mid-sized companies.
Regulatory Submissions and Follow-Up
Navigating regulatory requirements is a critical step in bringing medical products and devices to market. Our team of regulatory experts manages the entire submission process, ensuring that all necessary documentation is prepared and submitted accurately and timely. We handle:
Our thorough and proactive approach ensures that your regulatory submissions are handled efficiently, minimizing delays and facilitating a smooth approval process.
Medical Products and Devices Registration and Market Entry
Entering new markets requires careful planning and execution. We provide comprehensive support to ensure your medical products and devices are registered and ready for market entry. Our services include:
Our team stays up-to-date with the latest regulatory changes and market trends, providing you with strategic insights and guidance to navigate the complexities of product registration and market entry.
Why Choose InSiGHt Health Clinical Ltd?
With InSiGHt Health Clinical Ltd, you can trust that your medical products and devices will navigate the regulatory landscape smoothly and reach the market efficiently. Partner with us to ensure the successful registration and launch of your products, driving your business forward with confidence and success.
OUR WORK
PROJECT OVERVIEW:
In 2023, InSiGHt Health Clinical Ltd successfully managed a Phase III multi-country, randomized, placebo-controlled, double-blinded adaptive platform trial. The trial was designed to assess the efficacy and safety of treatments for subjects with monkeypox virus disease
TRIAL DETAILS
Nature of the Study: Phase III, multi-country, randomized, placebo-controlled, double-blinded adaptive platform trial
Objective: To evaluate the efficacy and safety of treatments for monkeypox virus disease
Countries Involved: Nigeria, Democratic Republic of Congo, The Congo, Cameroon, Benin, Sudan, Mali, Ghana, Liberia, Central African Republic
ACCOMPLISHMENTS:
We successfully facilitated the registration of medical products for two prominent biotech companies with NAFDAC (National Agency for Food and Drug Administration and Control).
By acting as the country representative, we ensured a smooth and efficient registration process, navigating the regulatory landscape to meet all compliance requirements.
Our efforts enabled InTec Products, Inc. and Wondfo Biotech Co. Ltd to introduce their innovative products to the Nigerian market within the stipulated timelines.
Client: Wondfo Biotech Co. Ltd
Period: 2017-2019
Client: InTec Products, Inc.
Period: 2020-2022
Second Floor,
Wing A, 1 Morenikeji Street,
Allen, Ikeja, Lagos.
+234 813 900 9510
Elizade Place,
Central Business District,
Abuja.
+234 703 873 6845