Services
Effective Research offers a comprehensive range of clinical research services from Phase I-IV.
Effective Research can provide full clinical trial management services from inception to conclusion, or undertake specific parts of a project to supplement your research requirements. The choice is yours.
To expedite your project, Effective Research provides a dedicated multi-disciplinary team of professionals to execute your study. We're uniquely qualified to support your studies, because our management and staff have extensive experience in pharmaceutical and medical device clinical trials, supporting your clinical study throughout every step of the trial.
We understand that your clinical trial is a substantial investment — one you want to protect by choosing the right CRO partner. From randomized to double-blind to placebo-controlled studies or other designs — for simple or complex trials — our team of experts is prepared to conduct your project on-time and on-budget.
We recognize your unique needs and adapt to meet them. All while remaining committed to delivering operational excellence.
Effective Research can provide full clinical trial management services from inception to conclusion, or undertake specific parts of a project to supplement your research requirements. The choice is yours.
To expedite your project, Effective Research provides a dedicated multi-disciplinary team of professionals to execute your study. We're uniquely qualified to support your studies, because our management and staff have extensive experience in pharmaceutical and medical device clinical trials, supporting your clinical study throughout every step of the trial.
We understand that your clinical trial is a substantial investment — one you want to protect by choosing the right CRO partner. From randomized to double-blind to placebo-controlled studies or other designs — for simple or complex trials — our team of experts is prepared to conduct your project on-time and on-budget.
We recognize your unique needs and adapt to meet them. All while remaining committed to delivering operational excellence.
Clinical Monitoring
Our Clinical Research Associates (CRAs) are second to none. All our CRAs have several years of experience in a variety of therapeutic areas in medical device and pharmaceutical clinical trials.
Our CRAs adhere to following the SOPs provided for each study and are fully conversant with FDA and ICH guidelines for Good Clinical Practices. At the start of each study, CRAs receive project related training, including therapeutic area and disease-specific tutorials which enables our monitors to be up-and-running quickly. They also maintain strong relationships with their investigative sites, working with them to resolve enrollment barriers to ensure successful study progress.
And our CRAs are focused on keeping sites motivated and on track. At the same time, our CRAs work closely with the project's Clinical Data Management and Product Safety leads to ensure clinical data management and safety queries are addressed in a timely manner.
Effective Research CRAs are regionally based throughout the country which allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.
Monitoring visits are based on actual site enrollment. 100% source document verification is performed at these visits. We don’t continuously monitor poor enrolling sites. This decreases costs and increases clinical trial oversight. The CRA will prepare a report to document the activities performed at each visit.
Our CRAs adhere to following the SOPs provided for each study and are fully conversant with FDA and ICH guidelines for Good Clinical Practices. At the start of each study, CRAs receive project related training, including therapeutic area and disease-specific tutorials which enables our monitors to be up-and-running quickly. They also maintain strong relationships with their investigative sites, working with them to resolve enrollment barriers to ensure successful study progress.
And our CRAs are focused on keeping sites motivated and on track. At the same time, our CRAs work closely with the project's Clinical Data Management and Product Safety leads to ensure clinical data management and safety queries are addressed in a timely manner.
Effective Research CRAs are regionally based throughout the country which allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.
Monitoring visits are based on actual site enrollment. 100% source document verification is performed at these visits. We don’t continuously monitor poor enrolling sites. This decreases costs and increases clinical trial oversight. The CRA will prepare a report to document the activities performed at each visit.
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Each CRA will manage site visit objectives including:
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Project Management
Our project managers focus on providing on-time, on-cost quality deliverables.
Effective Research offers the services of clinical project managers with experience managing research projects and clinical trials.
The Project Managers at Effective Research are proactive, and responsive to our clients' needs. Additionally, our project managers work closely with data management, statisticians, and the monitoring team to tightly integrate the research process.
Effective Research offers the services of clinical project managers with experience managing research projects and clinical trials.
The Project Managers at Effective Research are proactive, and responsive to our clients' needs. Additionally, our project managers work closely with data management, statisticians, and the monitoring team to tightly integrate the research process.
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The Project Manager will be responsible for the following:
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Quality Assurance
Effective Research QA is an independent group that provides expert quality assurance services to pharmaceutical, biotechnology, and medical device companies. Whether you are looking to develop and implement quality systems from scratch, or need to standardize and review the compliance of your existing systems, or your contractors’ systems, Effective Research QA’s experienced team of auditors and QA professionals can help you. Our QA team is guided by GCP, federal regulations, and client specifications.
Rescue Studies
Sometimes, a sponsor can find themselves in the middle of a clinical trial that is not going as planned. Inadequate performance, whether in monitoring, project management, data collection and/or analysis, can jeopardize a study and set back the entire clinical development program. Proper corrective action and strategy can often save a rough situation.
Effective Research has taken over responsibility for a number of projects which got off track. Effective Research has the ability to resolve any clinical trial problem. Due to our experience in this area, we are able to move quickly to resolve your issues.
Effective Research has taken over responsibility for a number of projects which got off track. Effective Research has the ability to resolve any clinical trial problem. Due to our experience in this area, we are able to move quickly to resolve your issues.
We offer:
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Feasability Studies
Feasibility is a process of comprehensive analysis and planning, including risk mitigation and contingency planning. It is anchored in practical experience from similar completed trials that have met global regulatory scrutiny. Feasibility allows for the review of indication-specific data to provide enrollment, screen failure and retention analysis by drug class or phase. It can provide exceptional insight into successful clinical research strategies by therapeutic area, drug class, indication and protocol design. Feasibility analysis can lead to better study design, clinical study execution and proactive management of timelines.
A well-researched feasibility study is one of the key success factors for any clinical study; it is critical for both ‘go/no go’ and ‘how to’ decisions.
We provide comprehensive feasibility assessments and analysis to help our clients determine the most cost-effective and timely operational strategies for clinical trial or program execution.
Welcome to Effective Research - Highly reliable clinical research services specialist you can count on to deliver exceptional results.
Effective Research offers a comprehensive range of clinical research services from Phase I-IV. Effective Research provides clinical monitoring, project management, data management and statistical management services for clinical trials.
Clinical Monitoring: Our Clinical Research Associates (CRAs) are second to none. All our CRAs are highly trained and have several years of experience in a variety of therapeutic areas in medical device and pharmaceutical clinical trials.
Our CRAs adhere to following the SOPs provided for each study and are fully conversant with FDA and ICH guidelines for Good Clinical Practices. At the start of each study, CRAs receive project related training, including therapeutic area and disease-specific tutorials which enables our monitors to be up-and-running quickly. They also maintain strong relationships with their investigative sites, working with them to resolve enrollment barriers to ensure successful study progress.
Our CRAs are focused on keeping sites motivated and on track. At the same time, our CRAs work closely with the project's Clinical Data Management and Product Safety leads to ensure clinical data management and safety queries are addressed in a timely manner. Effective Research CRAs are regionally based throughout the country which allows us to maximize flexibility, reduce travel costs, and create an efficient and cost-effective monitoring process.
Our experience and deep knowledge of indication-specific protocol design, screen failure rates, manpower and training requirements, site integration and communication requirements, give us the edge in ensuring successful study execution.
A well-researched feasibility study is one of the key success factors for any clinical study; it is critical for both ‘go/no go’ and ‘how to’ decisions.
We provide comprehensive feasibility assessments and analysis to help our clients determine the most cost-effective and timely operational strategies for clinical trial or program execution.
Welcome to Effective Research - Highly reliable clinical research services specialist you can count on to deliver exceptional results.
Effective Research offers a comprehensive range of clinical research services from Phase I-IV. Effective Research provides clinical monitoring, project management, data management and statistical management services for clinical trials.
Clinical Monitoring: Our Clinical Research Associates (CRAs) are second to none. All our CRAs are highly trained and have several years of experience in a variety of therapeutic areas in medical device and pharmaceutical clinical trials.
Our CRAs adhere to following the SOPs provided for each study and are fully conversant with FDA and ICH guidelines for Good Clinical Practices. At the start of each study, CRAs receive project related training, including therapeutic area and disease-specific tutorials which enables our monitors to be up-and-running quickly. They also maintain strong relationships with their investigative sites, working with them to resolve enrollment barriers to ensure successful study progress.
Our CRAs are focused on keeping sites motivated and on track. At the same time, our CRAs work closely with the project's Clinical Data Management and Product Safety leads to ensure clinical data management and safety queries are addressed in a timely manner. Effective Research CRAs are regionally based throughout the country which allows us to maximize flexibility, reduce travel costs, and create an efficient and cost-effective monitoring process.
Our experience and deep knowledge of indication-specific protocol design, screen failure rates, manpower and training requirements, site integration and communication requirements, give us the edge in ensuring successful study execution.