Our Services
Our Services
Sponsor Medical Oversight
Clinical trial management strategies tend to be varied with different approaches applied by sponsors to satisfy the regulations which state that the sponsor is ultimately responsible for the conduct and reporting of trials (SI 2004/1031 Regulation 3).
Sponsors must have systems in place to ensure adequate oversight of both in-house and outsourced trial activities.
Our experts, as part of your R&D team, provide the mandated medical oversight and assure the regulatory compliance is maintained throughout the study, providing the space and freedom for the business to focus on building relationships that matter.
Our areas of expertise include reviews performed in the following areas:
Contracts and Agreements:
Study management agreements should cover the site and sponsor functions and communication plan that assures appropriate study related activities are conducted with clear accountability and oversight of the sponsor.
Medical Oversight Mechanisms:
A risk-based approach is recommended for overseeing vendors. The level of oversight depends on the tasks being performed and their potential impact on patient safety and data integrity.
Oversight methods include:
- Project Plans: When multiple vendors are involved, a communication plan should outline roles, processes, and issue escalation procedures.
- Project Meetings/Status Reports: Regular meetings with documented action items and status reports help track trial progress. Failure to act on issues can have serious consequences (Efficacy and Safety reviews at regular intervals)
- Medical Monitoring: Instream data reviews for maintaining study end-points and safety of clinical trial participants as per GCP requirements – for outsourced or in–house managed studies
- Issue Escalation: There must be a clear process for escalating significant issues to the sponsor, including the timely reporting of serious breaches.
- Vendor Assessment: This process, which may involve questionnaires, SOP reviews, site visits, or audits, ensures the vendor’s Quality Management System (QMS) meets regulatory standards. Audits should identify and report any potential breaches to the sponsor.
Improving Compliance:
Sponsors must ensure oversight not just of external vendors but also of internal teams and investigator sites. Lack of compliance in this area can lead to critical findings, hindering the organization from sponsoring future trials.
Sponsor oversight should be clearly defined in the QMS, and documentation of oversight activities should be maintained in the TMF. A risk-based approach should guide oversight activities, focusing on key areas with higher risk.
Benefits of early engagement with our professional team will allow savings of cost, quality, time and opportunity that ultimately allows positioning your organization on a path to success. Please schedule a call with our experts for a call.
Sponsor Medical Oversigh
Clinical trial management strategies tend to be varied with different approaches applied by sponsors to satisfy the regulations which state that the sponsor is ultimately responsible for the conduct and reporting of trials (SI 2004/1031 Regulation 3).
Sponsors must have systems in place to ensure adequate oversight of both in-house and outsourced trial activities.
Our experts, as part of your R&D team, provide the mandated medical oversight and assure the regulatory compliance is maintained throughout the study, providing the space and freedom for the business to focus on building relationships that matter.
Our areas of expertise include reviews performed in the following areas:
Contracts and Agreements:
Study management agreements should cover the site and sponsor functions and communication plan that assures appropriate study related activities are conducted with clear accountability and oversight of the sponsor.
Medical Oversight Mechanisms:
A risk-based approach is recommended for overseeing vendors. The level of oversight depends on the tasks being performed and their potential impact on patient safety and data integrity.
Oversight methods include:
- Project Plans: When multiple vendors are involved, a communication plan should outline roles, processes, and issue escalation procedures.
- Project Meetings/Status Reports: Regular meetings with documented action items and status reports help track trial progress. Failure to act on issues can have serious consequences (Efficacy and Safety reviews at regular intervals)
- Medical Monitoring: Instream data reviews for maintaining study end-points and safety of clinical trial participants as per GCP requirements – for outsourced or in–house managed studies
- Issue Escalation: There must be a clear process for escalating significant issues to the sponsor, including the timely reporting of serious breaches.
- Vendor Assessment: This process, which may involve questionnaires, SOP reviews, site visits, or audits, ensures the vendor’s Quality Management System (QMS) meets regulatory standards. Audits should identify and report any potential breaches to the sponsor.
Improving Compliance:
Sponsors must ensure oversight not just of external vendors but also of internal teams and investigator sites. Lack of compliance in this area can lead to critical findings, hindering the organization from sponsoring future trials.
Sponsor oversight should be clearly defined in the QMS, and documentation of oversight activities should be maintained in the TMF. A risk-based approach should guide oversight activities, focusing on key areas with higher risk.
Benefits of early engagement with our professional team will allow savings of cost, quality, time and opportunity that ultimately allows positioning your organization on a path to success. Please schedule a call with our experts for a call.
Clinical Trial Management
We are experienced and have been providing clinical trial management services to biotech as well as pharmaceutical organizations. We have established network with Key Opinion Leaders in Europe and Pakistan and can help with
Study Design: you give us the concept and we will review it both from regulatory as well as real life perspective. We can develop study design from a concept sheet within days compared to months
Feasibility: depending on the phase and design; we can not only conduct the feasibility for you, but we can also design a feasibility questionnaire which will ask the “right” questions, resulting in a response which will be informative. We achieve this as we have developed a “personal” relationship with healthcare professionals, and we can bypass most of the administrative delays.
Monitoring: We can provide you with Clinical Research Associates who may not be an expert in therapy area but are very good at their job. We believe that a CRA does not need to be an expert in the therapy area, that is the job of Principal Investigator. When we assign a CRA we train them with the basics needed for a therapy area and focus on their skills as a monitor, which has always resulted in a smooth data flow from
Analysis and Reporting: We provide full-service data management activities including acquisition/collection, abstraction/extraction, processing, coding, analysis, transmission, storage, privacy and quality assurance. Our clinicians, statisticians, programmers, data managers and other team members provide better clinical trial data, facilitating earlier insights for your drug development programs. We support clinical data management from data analysis to final data reporting. Our medical writers, clinicians, statisticians, programmers, data managers, analytical scientists and other members work together to assist you with all reporting documents. All documents will be submission ready to facilitate the next regulatory affairs.
Clinical Trial Management
We are experienced and have been providing clinical trial management services to biotech as well as pharmaceutical organizations. We have established network with Key Opinion Leaders in Europe and Pakistan and can help with
Study Design: you give us the concept and we will review it both from regulatory as well as real life perspective. We can develop study design from a concept sheet within days compared to months
Feasibility: depending on the phase and design; we can not only conduct the feasibility for you, but we can also design a feasibility questionnaire which will ask the “right” questions, resulting in a response which will be informative. We achieve this as we have developed a “personal” relationship with healthcare professionals, and we can bypass most of the administrative delays.
Monitoring: We can provide you with Clinical Research Associates who may not be an expert in therapy area but are very good at their job. We believe that a CRA does not need to be an expert in the therapy area, that is the job of Principal Investigator. When we assign a CRA we train them with the basics needed for a therapy area and focus on their skills as a monitor, which has always resulted in a smooth data flow from
Analysis and Reporting: We provide full-service data management activities including acquisition/collection, abstraction/extraction, processing, coding, analysis, transmission, storage, privacy and quality assurance. Our clinicians, statisticians, programmers, data managers and other team members provide better clinical trial data, facilitating earlier insights for your drug development programs. We support clinical data management from data analysis to final data reporting. Our medical writers, clinicians, statisticians, programmers, data managers, analytical scientists and other members work together to assist you with all reporting documents. All documents will be submission ready to facilitate the next regulatory affairs.
Regulatory Submission
We have access to an expert regulatory team, who are agile and efficient and can develop regulatory strategy with you depending on the objectives, our team has successfully led several IND and NDAs in all major markets. Our team has experience in preparing and defending orphan drug designations and fast track applications.
We can also work with you and define your needs and get pre-NDA advice from regulators this will minimize any afterwork and has proven to save time. We can prepare, submit and follow-up on the submission dossiers.
Regulatory Submission
We have access to an expert regulatory team, who are agile and efficient and can develop regulatory strategy with you depending on the objectives, our team has successfully led several IND and NDAs in all major markets. Our team has experience in preparing and defending orphan drug designations and fast track applications.
We can also work with you and define your needs and get pre-NDA advice from regulators this will minimize any afterwork and has proven to save time. We can prepare, submit and follow-up on the submission dossiers.
Regulatory Inspection
Over the past few years, we have undertaken several projects to make the organization ready for inspection. Our motto has always been to be inspection ready all the time. We can advise you on how to prepare of a regulatory inspection and also can put systems in place which will help you achieve 100% inspection readiness all the time.
By looking at your SOPs and working with your team we will ensure that regulatory inspections run smoothly with minimum disruption to your everyday business and our trained consultants will help address any anxiety or fear your staff may have due to a looming inspection. We have consultants who have been through multiple regulatory inspection and from experience they know the key trigger points and can prepare you and your staff.
Regulatory Inspection
Over the past few years, we have undertaken several projects to make the organization ready for inspection. Our motto has always been to be inspection ready all the time. We can advise you on how to prepare of a regulatory inspection and also can put systems in place which will help you achieve 100% inspection readiness all the time.
By looking at your SOPs and working with your team we will ensure that regulatory inspections run smoothly with minimum disruption to your everyday business and our trained consultants will help address any anxiety or fear your staff may have due to a looming inspection. We have consultants who have been through multiple regulatory inspection and from experience they know the key trigger points and can prepare you and your staff.
Training and Development
With access to therapy area experts as well as professionals from all the specialties within clinical research, we can tailor training and development for all levels of your staff. We have delivered numerous therapy area and study protocol related trainings and have conducted CRA and investigators meeting on behalf of sponsors.
We can also implement the training system for your organization, which will enable you to get rid of manual tracking of training records. Our systems are compliant with the current regulations and will ensure that your training records are inspection ready.
Training and Development
With access to therapy area experts as well as professionals from all the specialties within clinical research, we can tailor training and development for all levels of your staff. We have delivered numerous therapy area and study protocol related trainings and have conducted CRA and investigators meeting on behalf of sponsors.
We can also implement the training system for your organization, which will enable you to get rid of manual tracking of training records. Our systems are compliant with the current regulations and will ensure that your training records are inspection ready.
CRO Optimization
Over the past decade the CROs have become big organizations and with the ICH’s focus on Sponsor Oversight it is very important for every sponsor organization to make sure that they are compliant with the current regulations and guidelines. Majority of the large pharmaceutical organizations have adopted “Alliance Models” which cover all aspects of oversight. However, this is something which is generally lacking in the medium or small Biotech organization.
As we have experts who have multidisciplinary experience, we can help you find and manage a CRO which will be fit for purpose. Depending on the type of clinical trial we can not only find “suitable” CRO for you; we can also negotiate the best price and service so not only your project is delivered with quality and agreed timeframe; we try to keep it within budget too.
CRO Optimization
Over the past decade the CROs have become big organizations and with the ICH’s focus on Sponsor Oversight it is very important for every sponsor organization to make sure that they are compliant with the current regulations and guidelines. Majority of the large pharmaceutical organizations have adopted “Alliance Models” which cover all aspects of oversight. However, this is something which is generally lacking in the medium or small Biotech organization.
As we have experts who have multidisciplinary experience, we can help you find and manage a CRO which will be fit for purpose. Depending on the type of clinical trial we can not only find “suitable” CRO for you; we can also negotiate the best price and service so not only your project is delivered with quality and agreed timeframe; we try to keep it within budget too.
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