Project Management
Over 10 years, ATCGen has benefited its clients through the management of science projects from their beginning until completion. Our project management team has wide experience and qualification for managing and delivering results within the required scope, term and budget. Our responsibilities in project management include the following:
- Management of the general schedule, assuring that the work is assigned to the appropriate resources and it is completed within the set term and budget.
- Identification, management and resolution of main problems.
- Proactive management, ensuring that what has been agreed upon is delivered, including the requested modifications which have been approved.
- Release of project information to the interested parties.
- Project risks identification and management.
- Guarantee that the solution complies with the quality the client needs.
- Definition and accomplishment of the appropriate metrics for an accurate vision of the project progress and the quality of the produced deliverables.
Additionally, ATCGen also provides training for the client team, in case the client is interested in actively participating in the global management of the study.
CRF and Data Management
We are the first CRO in Brazil to have a database which can be fed in real time enabling remote access to the parties involved whenever they need and wherever they are.
ATCGen creates a database for scientific research and a password for the client. By means of that password, the client has access to all information regarding the study: management, monitoring, reports, records and other key documents.
ATCGen also provides data input services. We have a typing team able to perform the task in an efficient and fast manner.
ATCGen has an eCRF system especially created for clinical, observational or epidemiological studies integrated to the database. All platforms are accessed over the Internet.
Monitoring
ATCGen offers monitoring services for clinical, analytical, pharmaceutical, and bioequivalence/bioavailability studies. Monitoring is carried out by monitors specialized in several therapeutic areas, always following a monitoring plan previously approved by the client.
Apart from site and remote monitoring, monitors also pay visits upon the beginning and the closing of the study.
Scientific Advise
Writing of study protocols.
We know that the quality of the study protocol and CRFs are a key aspect for the research success; that is why whenever we are hired for that type of consultancy we focus in all the multidisciplinary team for the task. Our excellent contact with the medical network also gives us the advantage of having specialists at close reach whenever that is necessary.
ATCGen also supports the client through protocol defense meetings before ANVISA, for instance, by sending one of its specialists whenever necessary.
Experiment Planning and Guidelines
Paramount phase of any research project which aims to statistically analyze variables of interest, planning is the main critical point regarding the most common errors in research. Structuring the proper guidelines in order to attain solid and unchallengeable results is, undoubtedly, the key to success to potentiate results and minimize costs.
Statistic services
ATCGen has a team of professionals which offer statistical support for scientific research.
Key services: crossover, parallel and block studies (randomized or Latin squares), subject (or product) randomization processes , guidelines for longitudinal studies with or without censorship, among others.
Sample Calculation
Key factor for the use of manpower and subjects in an adequate and optimized way in sample planning. This critical and fundamental procedure, conciliated with sample guidelines, ensures the viability of the results obtained.
Key services: crossover, parallel, random and sampling procedures; cluster sampling (multiple stages), for parametric and non-parametric statistical tests, linear models, among others.
Epidemiological studies
Epidemiological studies are the most used analysis for ascertaining important factors and fundamental characteristics of the behavior of the subjects under study. Several current diseases with no final cure use this type of research in order to try to build up behavior profiles and associations between risk factors for understanding and decision making purposes for the correct conduction of treatments.
Key services: epidemiological studies of several types: observational, transversal or prevalence, case-control and cohort.
Training
ATCGen team understands that providing training for the working team is a way to grow and many times the company on its own has no conditions to provide training for its assistants. The training we offer is tailored to the client needs and can be provided in a specific location or at the client´s main place of business.
Some of the courses we offer: training in Good Clinical Practice, Bioequivalence and Bioavailability, Statistics and other.