OUR SERVICES

Consultancy  |  Clinical Management  |  Outsourcing  |  Quality Assurance

CONSULTANCY SERVICES

Whether you are considering Latin America as a sole territory for a particular trial, as part of a wider international program or as part of the rescue plan for an ongoing study, ReSolution Latin America can advise and direct you. Our internal expertise supplemented by access to experienced consultants, as well as ReSNET (the ReSolution Investigator NETwork), enables us to offer our Sponsors access to unrivalled expertise.

Latin America is our niche and we specialize in advising and guiding our Sponsors in the region. We provide expert, unbiased advice ensuring that your clinical development program embarks in the optimal direction. We understand local and regional idiosyncrasies in a region where one size does not fit all.

Not all protocols are suitable for Latin America and there is also variability in terms of which countries can participate in a particular protocol. Clearly, there are times when these obstacles cannot be overcome and the region is ruled-out. However, protocols are sometimes ruled-out when, in fact, a bit of lateral thinking can remove these obstacles thereby enabling the region to provide an excellent contribution.

ReSolution Latin America:

1. Evaluates each client’s particular requirements within the context of the goals and timelines of each individual project.

2. Proactively offers solutions and advice.

3. Prevents clients from embarking in non-optimal directions.

The Regulatory procedures in Latin America can seem complicated and, though the regulatory framework is generally well-defined, it warrants careful and proactive management. A clearly thought-out strategy, seamless execution and effective follow-up all serve to avoid delay.

Whether your requirement calls for advice and direction on the optimal strategy to be adopted for obtaining regulatory approval to the compilation and submission of the regulatory dossier, ReSolution Latin America can support you.

ReSolution Latin America:

1. Designs and, in conjunction with our clients, decides on the exact strategy to be adopted.

2. Effectively follows and proactively manages the regulatory process from the planning stage all the way through to approval. Projected timelines and milestones are set-out and closely tracked.

3. Keeps our Sponsors, Investigators and ReSolution Latin America’s Project Teams up-to-date on the process, thereby enabling all functions to be on standby ready to commence as soon as approval is obtained.

2. Proactively offers solutions and advice.

3. Prevents clients from embarking in non-optimal directions.

We have a direct line to the investigators and sites where the trial could be conducted. This gives us the ability to quickly and accurately pre-evaluate clinical protocols and to gauge important factors such as suitability to the region (and where in the region), recruitment potential, as well as to identify potential protocol-specific pitfalls and key success factors. Feasibility results are used to supplement our internal expertise enabling us to guide our Sponsors based on a combination of experience and empirical data.

ReSolution Latin America:

1. Provides an initial expert assessment of each protocol for suitability and advises on the overall strategy that should be adopted.

2. Evaluates the protocol with the relevant staff depending on therapeutic area, indication and product type.

3. Prepares feasibility documentation along with questionnaires designed to obtain relevant information from potential investigators.

4. Approaches potential investigators with details of the protocol and assessment questionnaires.

5. Whether through a full Feasibility Report or through round-table discussions, provides the Sponsor with sound advice and direction on which the ultimate strategy is based.

Latin America may seem far away to many Sponsors and it is sometimes difficult to gauge whether or not any progress is actually being made or even what level of priority your project is being given. If this is a concern, having a local third-party offering unbiased assessment of the situation, along with support, can be an attractive proposition.

ReSolution Latin America:

1. Will assess the situation, gauging what aspects are working, which are not and what needs to happen to get the study back on track in order to avoid/minimize further delay.

2. Will act as a nexus between the CRO and Sponsor supervising and, if appropriate, directing progress to ensure timelines are maintained and further pitfalls are avoided.

The value of setting-up Expert Focus Groups can be many and varied. A protocol which is suitable for the United States or Europe is not necessarily so (throughout) Latin America. The reasons for this can be multi-factorial and are not always obvious. Furthermore, as Latin America continues to gain ground as an end-consumer of pharmaceuticals, drug development companies are increasingly taking the region into consideration for commercialization and marketing purposes.

ReSolution Latin America:

1. Can quickly set-up these types of meetings ensuring that the Expert Panel is comprised of the right expertise whilst avoiding the temptation for these forums to be too extensive in terms of participation.

2. Ensures that maximum value is obtained from these meetings and that this translates into tangible strategic benefits to the project.

2. Will act as a nexus between the CRO and Sponsor supervising and, if appropriate, directing progress to ensure timelines are maintained and further pitfalls are avoided.

CLINICAL MANAGEMENT SERVICES

ReSolution Latin America’s focus is on clinical research specifically in Latin America. As such, we know how to plan, implement and execute your study enabling you to reach and exceed your targets.

Our set-up and procedures, including our SOPs, are designed to match global standards and expectations to the realities of regional execution. Data from Latin America must obviously match that from other regions. This is what we ensure.

The caliber of our staff is the key to this. ReSolution Latin America’s philosophy is for our Project Teams to act as an extension of our Sponsors’ clinical departments. It is our belief that, by integrating the two, we foster a sense of ownership and accountability, thereby creating an environment in which everyone strives towards a common goal- the success of the project.

Our Project Team members are results-driven but they are held accountable to metrics and results that are important to our Sponsors rather than endless realization and percentage allocation reports.

OUTSOURCING SERVICES

ReSolution Latin America recognizes the importance of assigning experienced clinical research professionals to your studies and the challenges associated with this given the competitive environment. We are also sensitive to the particular issues of outsourcing staff in terms of being able to attract and retain talent.

Our Company policies and structure have been designed to address and overcome these issues. A positive working environment, a sense of ownership and a rewards-driven culture are all conducive to the high stability of our Project Teams.

Whether your requirements are for long term support or a particular issue you need to scale-up for, ReSolution Latin America can help. Our efficient set-up and lean infrastructure allows us to offer this service very cost-effectively.

QUALITY ASSURANCE SERVICES

Quality is ReSolution Latin America’s backbone and, as such, we invest significantly in the Quality Assurance aspect of our operations. Through the robustness of our internal Quality System which has been repeatedly audited, the QA aspect is fully integrated into all the Company´s activities.

This enables us to offer a service which is unrivaled in the region and a par with the highest global standards.

Whether your requirement calls for a few site audits to a comprehensive study audit, ReSolution Latin America can support you.

OUR SERVICES

Consultancy  |  Clinical Management  |  Outsourcing  |  Quality Assurance

CONSULTANCY SERVICES

Whether you are considering Latin America as a sole territory for a particular trial, as part of a wider international program or as part of the rescue plan for an ongoing study, ReSolution Latin America can advise and direct you. Our internal expertise supplemented by access to experienced consultants, as well as ReSNET (the ReSolution Investigator NETwork), enables us to offer our Sponsors access to unrivalled expertise.

Latin America is our niche and we specialize in advising and guiding our Sponsors in the region. We provide expert, unbiased advice ensuring that your clinical development program embarks in the optimal direction. We understand local and regional idiosyncrasies in a region where one size does not fit all.

Not all protocols are suitable for Latin America and there is also variability in terms of which countries can participate in a particular protocol. Clearly, there are times when these obstacles cannot be overcome and the region is ruled-out. However, protocols are sometimes ruled-out when, in fact, a bit of lateral thinking can remove these obstacles thereby enabling the region to provide an excellent contribution.

ReSolution Latin America:

1. Evaluates each client’s particular requirements within the context of the goals and timelines of each individual project.

2. Proactively offers solutions and advice.

3. Prevents clients from embarking in non-optimal directions.

The Regulatory procedures in Latin America can seem complicated and, though the regulatory framework is generally well-defined, it warrants careful and proactive management. A clearly thought-out strategy, seamless execution and effective follow-up all serve to avoid delay.

Whether your requirement calls for advice and direction on the optimal strategy to be adopted for obtaining regulatory approval to the compilation and submission of the regulatory dossier, ReSolution Latin America can support you.

ReSolution Latin America:

1. Designs and, in conjunction with our clients, decides on the exact strategy to be adopted.

2. Effectively follows and proactively manages the regulatory process from the planning stage all the way through to approval. Projected timelines and milestones are set-out and closely tracked.

3. Keeps our Sponsors, Investigators and ReSolution Latin America’s Project Teams up-to-date on the process, thereby enabling all functions to be on standby ready to commence as soon as approval is obtained.

2. Proactively offers solutions and advice.

3. Prevents clients from embarking in non-optimal directions.

We have a direct line to the investigators and sites where the trial could be conducted. This gives us the ability to quickly and accurately pre-evaluate clinical protocols and to gauge important factors such as suitability to the region (and where in the region), recruitment potential, as well as to identify potential protocol-specific pitfalls and key success factors. Feasibility results are used to supplement our internal expertise enabling us to guide our Sponsors based on a combination of experience and empirical data.

ReSolution Latin America:

1. Provides an initial expert assessment of each protocol for suitability and advises on the overall strategy that should be adopted.

2. Evaluates the protocol with the relevant staff depending on therapeutic area, indication and product type.

3. Prepares feasibility documentation along with questionnaires designed to obtain relevant information from potential investigators.

4. Approaches potential investigators with details of the protocol and assessment questionnaires.

5. Whether through a full Feasibility Report or through round-table discussions, provides the Sponsor with sound advice and direction on which the ultimate strategy is based.

Latin America may seem far away to many Sponsors and it is sometimes difficult to gauge whether or not any progress is actually being made or even what level of priority your project is being given. If this is a concern, having a local third-party offering unbiased assessment of the situation, along with support, can be an attractive proposition.

ReSolution Latin America:

1. Will assess the situation, gauging what aspects are working, which are not and what needs to happen to get the study back on track in order to avoid/minimize further delay.

2. Will act as a nexus between the CRO and Sponsor supervising and, if appropriate, directing progress to ensure timelines are maintained and further pitfalls are avoided.

The value of setting-up Expert Focus Groups can be many and varied. A protocol which is suitable for the United States or Europe is not necessarily so (throughout) Latin America. The reasons for this can be multi-factorial and are not always obvious. Furthermore, as Latin America continues to gain ground as an end-consumer of pharmaceuticals, drug development companies are increasingly taking the region into consideration for commercialization and marketing purposes.

ReSolution Latin America:

1. Can quickly set-up these types of meetings ensuring that the Expert Panel is comprised of the right expertise whilst avoiding the temptation for these forums to be too extensive in terms of participation.

2. Ensures that maximum value is obtained from these meetings and that this translates into tangible strategic benefits to the project.

2. Will act as a nexus between the CRO and Sponsor supervising and, if appropriate, directing progress to ensure timelines are maintained and further pitfalls are avoided.

CLINICAL MANAGEMENT SERVICES

ReSolution Latin America’s focus is on clinical research specifically in Latin America. As such, we know how to plan, implement and execute your study enabling you to reach and exceed your targets.

Our set-up and procedures, including our SOPs, are designed to match global standards and expectations to the realities of regional execution. Data from Latin America must obviously match that from other regions. This is what we ensure.

The caliber of our staff is the key to this. ReSolution Latin America’s philosophy is for our Project Teams to act as an extension of our Sponsors’ clinical departments. It is our belief that, by integrating the two, we foster a sense of ownership and accountability, thereby creating an environment in which everyone strives towards a common goal- the success of the project.

Our Project Team members are results-driven but they are held accountable to metrics and results that are important to our Sponsors rather than endless realization and percentage allocation reports.

OUTSOURCING SERVICES

ReSolution Latin America recognizes the importance of assigning experienced clinical research professionals to your studies and the challenges associated with this given the competitive environment. We are also sensitive to the particular issues of outsourcing staff in terms of being able to attract and retain talent.

Our Company policies and structure have been designed to address and overcome these issues. A positive working environment, a sense of ownership and a rewards-driven culture are all conducive to the high stability of our Project Teams.

Whether your requirements are for long term support or a particular issue you need to scale-up for, ReSolution Latin America can help. Our efficient set-up and lean infrastructure allows us to offer this service very cost-effectively.

QUALITY ASSURANCE SERVICES

Quality is ReSolution Latin America’s backbone and, as such, we invest significantly in the Quality Assurance aspect of our operations. Through the robustness of our internal Quality System which has been repeatedly audited, the QA aspect is fully integrated into all the Company´s activities.

This enables us to offer a service which is unrivaled in the region and a par with the highest global standards.

Whether your requirement calls for a few site audits to a comprehensive study audit, ReSolution Latin America can support you.