Phases II-III


We cover each and every task for the development of a clinical trial, providing the full service or a specific task.
We offer customized solutions with deep knowledge of the local/regional rules and cultures.
By adding flexibility to our scientific strength, operational experience, and academic background, we reach the goal under the highest quality standards.

Protocol Design and CRF
We generate the most feasible protocol and the one that better allows achieving the goal.
Combining our more than twenty years of experience in regulatory affairs, we design projects and protocol considerations fitting to the regulations and culture of each country of the region.
Using the proper local wording, we help in making a global protocol locally understandable for sites, patients, committees and agencies.
Our experience as investigators, allows us to provide advice for the building of friendly CRFs, either printed or electronic, reflecting the requirements of the protocol, facilitating data management and efficiently reducing the number of queries.

Statistical Design and Analysis
We work along with our client on the best statistical design for reaching the goal with the smallest possible sample; reducing approval timelines, accelerating recruitment and avoiding unnecessary costs.
Our medical team, with solid academic background, works together with statisticians in a final report.

Feasibility
We provide an accurate feasibility assessment for each project in each country, along with the recommendations to obtain the best quality in the shortest possible time and with maximum efficiency.
Supported by our local experts in each of the countries, and in close contact with KOLs, we obtain fist hand expert information.
Combination that information with our understanding of a global project we offer our clients a range of possible strategies for the development of its project in the region
Also considering regulatory environment, and under the leadership our Medical Advisors we:
– Evaluate the feasibility of the protocol or the summary provided by our client.
– Design the most efficient protocol.
– Recommend customization, if absolutely necessary, that facilitates the recruitment and the approval, reduces time and costs.
– Suggest which countries should be included (or not) and how many sites in each country.
– Provide our client with the blinded collected data, its analysis and the results and recommendations.
CREOS provides an accurate feasibility assessment for each project in each country, along with the recommendations to obtain the best quality in the shortest possible time and with maximum efficiency.

Regulatory affairs
Some of CREOS managers have worked in the Argentine Regulatory Agency (ANMAT) almost from the dawn of its creation.
With large and extensive experience in managing regulatory affairs in the region, and with deep and updated knowledge of the regulations, we can recommend the best regulatory strategies.
As a part of our proposals, we take into account the whole regulatory process and proactively recommend the proper strategies, the need of time demanding documents, and the possible queries from IRBs, Committees and Agencies.
Thus, timelines and needs to accomplish the approval are clearly informed to our client from the beginning; along with “saving time” recommendations.
Our knowledge of regional culture and rules allows us to predict possible objections, avoiding unnecessary delays.

Our experience in pharmaceutics companies allows us to understand our client’s internal needs and timelines. .
Our experience in CROs allows us to know feasible shortcuts and time reducing procedures.
Our experience as investigators, allows us to know the best way to obtain the tight collaboration of each of the sites in the regulatory process.

CREOS is one of the companies with largest experience in the management of regulatory affairs, holding one of the highest levels of efficiency.

Project Management
We consider that the most simple of the Project Management models is the most efficient and the one; facilitating the best results.
According to the size of the project, the Project Manager is exclusively assigned to one clinical trial, with full and exclusive dedication.
Our project managers are real operational leaders and trial facilitators.
The assigned Project Manager coordinates the tasks of the whole team and is the main contact with the client.
The Project Manager centralizes information updated on daily bases and keeps the client informed about the progress of the study, according to the communication plan.
PM is responsible of developing and carrying out the work order and contingency plans.
Besides their vast experience in groups’ management, our PM receives permanent medical support in different therapeutic areas.
The PM keeps the budget updated and the trial inside the budget.

Site Management and Clinical Monitoring
Experience, reliability and flexibility are the basic background required for any new CRA joining CREOS.
Depending on the project, we assign CRAs with different levels of experience but all of them are continuously trained in all aspects of clinical research.
This general vision, allows them to be focused on their specific task but understanding the project as a whole.

They are real facilitators, watching over the strict compliance of the GCP, guiding the investigator and his team the highest quality and to reach reaching efficiencies.

They participate in:
• The selection of sites, providing results of previous experiences with potential sites.
• Selection and qualification visits, checking if the site actually covers the needs of the project.
• Site Initiation, interim and close-out visits strictly observing the monitoring plan and SOP.
• IRB and EC approvals.
• Training visits.
• Corrective actions.
• Inspections and audits (Sponsor, agencies and Committees).
• Queries resolution.
• Application of contingency plans.
• Pro-active follow-up of the screening and recruitment.
• Study materials accountability

Several of our CRAs are specifically trained and experienced in the management of no intervention trials as well as in remote monitoring.
Almost ten years ago CREOS decided to start training CRAS in those areas, in understanding that the traditional experience and training implied difficulties for the CRA in the development of his tasks when working in non-traditional studies.
Our CRAs have managed to carry out no intervention studies reaching the highest quality, following GCP, and accomplishing the goal.

Quality assurance

Providing the best quality of services, to obtain the best quality of clean data, under the highest standards of quality is our minimum goal.
QA is always involved in each and every step of the projects we conduct.
Updating SOP and overseeing training programs is QA’s realm of responsibility.

Medical Affairs and Drug Safety

CREOS is a company created and led by medical doctors.
The Medical Monitor assigned to each clinical trial is a key reference point for investigators, Project Manager, CRAs and Sponsor.
Besides their medical area of expertise, or Medical Monitors are experienced in the methodology of clinical research
Their experience in the region along with their medical background enable them provide support to the whole research team.
Based on their background and on a deep and detailed knowledge of the protocol, they develop a professional relationship with investigators, easily solving all challenges in a clinical trial.
Our medical doctors:
• Lead country and protocol feasibility assessment
• Provide medical monitoring of clinical trials in all phases.
• Can cover the role of Medical Director if the Sponsor prefers relays that responsibility on us.
• Lead discussions with Key Opinion Leaders for the design of the most suitable project.
• Actively participate in the follow up and recruitment strategies.
• As medical reviewers, they follow up of laboratories and CRFs.
• Provide support for queries resolution.
• Train the investigation team in the medical subjects of the clinical trial.
• Actively participate in the Investigator Meetings.
• Are the responsible of the reports and the processing of adverse events (SAE).
• Edit the narratives and support the investigator in the communications to the committees and agencies.
• Design and develop training programs to train doctors non-experienced in clinical research; according to CREOS’ mission

Data Management
Friendly and suitable database allow clean data to reduce the number of unnecessary queries.
We provide paper and e-CRF; EDC; data entry and high security hosting.
We provide:
• Data Base set-up.
• Data entry for paper CRF.
• e-CRF.
• Electronic Data Capture
• Statistical Design.
• Statistical Analysis
• High security data Hosting

Site Contracts
We can build contracts and discuss CTAs with the sites.
Cultural and regulatory aspects in each country require customization of global CTA’s templates to avoid unnecessary delays.
By using the proper local wording CREOS easily adapt a global template into the required form.
Deep knowledge of the culture and a proper relationship with PIs and institutions allows a easier, faster and more suitable agreement.
CREOS is also a good facilitator in the discussion of fees with Investigators.
As a part of our full service, we also administrate payments to PIs.

Central Lab
Through our associated Central Laboratory, with regional coverage, we provide:
• Biological sampling
• Samples transportation
• Centralized Analysis
• Online follow up of the results

Logistics

Along with our Customs Agents and our partner storage/distribution vendor, we cover study materials logistic, taking care of:
• Imports
• Storage
• Distribution
• Recovery/Recall
• Destruction or re-exportation
• Imports/exports of biological samples
CREOS team coordinates the whole logistics process by centralizing contacts between the usually multiple providers of study materials and local importers.
In a task involving multiple players, we can accomplishing a high level of efficiency and avoid additional costs and unnecessary delays

Investigator Meeting
Along with our associate Meeting Planner we have been organizing successful Investigator and CRA Meetings.
We provide:
• Location
• Transfers
• Catering
• Material
• Simultaneous Translations

Insurance

Requirements for a Clinical Trial Insurance change from country to country.
We provide advisement to our client about how to handle this tasks as globally as possible, but customized to each country needs.

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