- Human Medicines, Biopharmaceuticals, …
- Service category
- Pre-clinical development and testing, pre-clinical CRO, Clinical development and testing, clinical CRO, …
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- Audit / compliance service
- Clinical data service / data management
- Clinical trial services
- Project management
- Statistical service / biostatistics / biometrics
Altizem offers a quality project’s management :
- Managers from operating team: for us as well as for you, the business skill is essential.
- Privileged and dedicated interlocutor in a permanent back-up.
- Follow-up of your studies 24/24 or 7/7 thanks to Altitrack, our online management tool of your studies.
- Promptness and availability of our Project Leaders.
- The same contact throughout the duration of the project: due to the very low turnover.
- An expertise in communication with our different interlocutors (Project leader, Product Manager, Doctor, Data Manager, Statistician ...)
With our experience, we support you for the design of your studies or surveys. The design will be done in close collaboration with you in order to provide your better answers for your expectations. The design is one of the crucial steps in the achievement of your studies, it requires a correlated work within our qualified team.
We are involved in the design of the study in its entirety or in its specific part: feasibility study, study design and documentation (protocol, CRF…) regulatory submission, assessment criteria, number of needed subjects, biostatistical methodology, printing and managing of study documentation ...
The quality of Monitoring is one of the main elements of data quality of our trials or surveys.
We are aware of your demands and we are able to bring your projects to a very high quality data with a management of studies performed by qualified project leaders and dedicated CRA who are able to meet your expectations.
- Selection of investigational centers
- Initiation visit
- Presentation of study related documents.
- Pharmacovigilance (EIG).
- Signature of study related documents (Protocol, Study related contracts, financial contracts ...)
- Check that all materials/equipments necessary to the conduct of the study are available at each investigational site.
- Routine on-site visit
- Review CRF and Queries data versus source documentations.
- Review of Adverses Events and Serious Adverse Events.
- Site closure visit
- Monitor the last queries answered by the investigator.
- Check that all documents are duly signed on Investigator file.
- Inform the sites of any potential contact for further request and of archiving the Study documents during 15 years at least.
- Collect of all documents including study related accounts.
Our qualified CRAs are involved in all steps of monitoring during the study (CRFs, questionnaires, diaries, queries…) and being support to the investigators throughout the trial. The Project Leader, who is the guarantee of respect of your goal, manages the CRAs team dedicated to your project.
The randomization is the only way to avoid bias in the selection; it is therefore an essential step in the study. Altizem is offering you the whole services related to managing randomization activities of your study.
The Biostatistics department generates the randomization list that will be later used by the investigators via website, e-mails, fax or “IVRS” (Interactive Voice Response System).
The avaibility and the consistencies of data are the major challenge in your studies. We made them as our leitmotiv and when the trials or the surveys are carried out by Altizem, the Data Management activities performed by Altizem team provide our customers high quality data and this is done in the best timelines. Thereby, our experimented Data Managers carry out any kind of projects by using different methods, according to the requirements of every customer.
- Paper CRF” Data management
- Being involved in many large scale projects for many years, we are able to offer you our expertise and to carry out your international projects.
- We adapt us to your expectations and can provide you solutions according to your target.
e-CRF Data management
Listening to your needs, we provide you support for the set-up of your projects on e-CRF, by using either the tool “Inform” in collaboration with “Phase Forward” or other e-CRF tools. We adapt us to your project. Thus, we use many different tools.
- Direct Management of the trial.
- Significant time saving.
- Best quality of data.
- A privileged communication tool.
- The current needs urge you today to perform analysis on group of studies by using “Data Pooling” of studies that have been performed on different means. We became experts on this field and know how to homogenize your databases by collecting necessary information related to the development of your data.
- Database design
- Annotated CRF.
- Database design and set-up (structure and data entry screen).
- CRF and DCF flow
- Tracking of CRF and DCF receipt.
- Data Management status and follow-up.
- Internal Data Entry
- Writing data entry guideline.
- Training of data entry people on Data Entry Conventions.
- Single Data Entry.
- Interactive double data entry.
- Independent double blind data entry.
- Quality control of data entry.
- External Data loading
- Laboratory data.
- ECG ...
- Coding of Adverse Events, Medical Histories, ECG reading and medications performed by a coding specialist with MedDRA, WHOdrug dictionaries or any other dictionaries provided by the Sponsor.
- Write data validation plan (edit checks).
- Program test and validate data validation edit checks.
- Generate listings of data validation edit checks.
- Manage queries.
- Patient Profile
- Define and program patient profile specifications according to the needs of the Sponsor.
- Data layout and interaction with Expert Committee.
- Data Review
- Drafting of Data Management Report.
- Preparation of Data Report Review.
- Data Review meeting.
- Intermediate and final database lock.
Each stage and documents are validated by an independent Data Manager before sending them to the Sponsor.
To comply with regulatory requirements, we were equipped, from the beginning, with the best software packages validated by the FDA (Clintrial and SAS) and since several years now, we are using the e-CRF. Furthemore, we have internally developed a study management tool: Altitrack, in order to optimize the follow-up of your studies or surveys (24/24 h and 7/7 days).
We have a recognized expertise in term of new technologies, we adapt to your requirements as we have the experience.
Altizem offers you the entire management of Serious Adverse Events of your national and international trials.
- Training and support of site investigator for the management of Adverse Events and Serious Adverse Events
- Collection, processing and sending notification to health authority of Serious Adverse Events.
- Risk Management plan.
- Notification to Ethic Committee.
- Writing of reports and narratives.
- Follow-up and reconciliation of pharmacovigilance and clinical databases.
Statistical analysis skills
We have acquired good statistical knowledges and know their application:
- Descriptive statistics.
- Parametric and non-parametric tests.
- Equivalent and non-inferiority tests.
- Comparisons and multiple tests.
- Generalized linear models.
- Non-linear models.
- Mixed models.
- Analysis of survival (Cos model, Kaplan Meier and actuarial Methods).
- Meta analysis ...
We mainly use SAS software (SAS base, SAS stat, SAS graph, SAS macro) to perform your analysis but we can use as well other statistical softwares according to your requirements.
We carry out in every step of your study:
- Writing the analysis section of a protocol.
- Calculation of Number of patients planned
- Creation of randomization list.
- Wring of statistical Analysis Plan.
- Edition of statistical analysis (tables, listings and graphs) and invididual data listings.
- Writing of Statistical report complying with ICH standards.
- Advise on Statistical methods to be used.
We assure you on fast and quality work:
- Every document is validated by an independent statistician or SAS programmer before sending to the Sponsor.
- We have documents and standard programs available for each of stages performed during the Statistical analysis of your studies.
Our team of doctors writes your reports of clinical studies, marketing or survey in agreement with the international recommendations, complying the standard procedures of Altizem and your standard procedures. We draft your reports by targeting your future objectives: submission report, publishing, poster, abstract, communication ...
- Write text and appendices.
- Medical review and clinical reading/interpretation of efficacy and tolerance data.
- Integration of narratives.
- Integration of tables.
- Implementation of tables and figures that are not included in the text and contained in the appendices of the biostatistical report.
- Presentation of reports according to your demands/requirements.
- Quality control of medical writing.
Our experimented medical writers will know how to bring to a successful conclusion your reports, publishings, posters, communications ... by emphasizing the results of your studies.
We have performed about twenty audits for the biggest health companies, in order to check the good achievement of the studies on all activities or on a particular expertise: monitoring, data management, statistical analysis, medical writing…, performed internally by our customers or managed by external CRO.
We ensure for your account the compliance with the good Clinical Practices, the ICH standards and the CDISC standards, 21 CFR Part 11 standards as well as the reliability and the consistency of the data in your projects.
Expertise / Insourcing Services
We also offer the service of our specialized consultants to bring to success your clinical studies, marketing, epidemiologic or medico-economic surveys:
- Project leader.
- Clinical Research assistant.
- Data Entry Operator.
- Data Manager.
- Data Base Designer.
- Coding Officer.
- SAS Programmer.
- Regulatory business pharmacist ...
We obtain recognition of our customers on our offer of Insourcing service:
- Prompt response to your requirements.
- Recruitment of experimented, qualified and motivated consultants.
- Specialized associates and involved in the development of the sector.
- Every associate in supervised by a manager of Altizem.
- Follow-up of each mission in order to give satisfaction to our customers.
- A guarantee of constant services.
Internal policy to allow associates:
- To evolve/advance within the profession.
- To adapt themselves continuously to the expectations of the market thanks to targeted trainings.
Approvals, Certificates, Authorisations
- CFR 21 Part 11
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