APLUSA REAL WORLD
"Evaluating and confirming the safety and the potential benefit of new therapeutic options in routine clinical practice bridges an important gap in the clinicians’ and health authorities’ knowledge for the benefit of the patient. Patient chart based data inform practice and monitor trends and patient outcomes. In parallel, the patient voice is becoming more important as healthcare moves to a value-based, patient-centered system of care. AplusA Real World developed extensive experience in both real world data collection and patient interviews."
Christine Maï, MD
AplusA Real World Supervisor
ETHIC COMMITTEE - IRB SUBMISSION
Our experts and legal teams will provide you with the accurate and specific guidance on local requirements you need to get EC/IRB approvals.
Our experts will design the most cost-and time-effective strategy, based on your study specifications and local regulations. Our worldwide network of local CRAs enables to perform the submission to EC/IRB in more than 30 countries. Choose a facilitated process with our local CRAs managing all activities from site enrollment and feasibility assessment, to EC approvals, contracting and Site monitoring.
EXPERT IN COLLECTING REAL WORLD DATA
Prospective & retrospective
• Focus groups - Mini Groups
• Advanced cognitive techniques
• Patient charts studies
• Online, mobile, mail, telephone
PATIENT CENTERED OUTCOMES
• Wide scope of patients and caregivers:
from chronic diseases to rare diseases
• Self-reported or physician confirmed diagnosis
• High quality and certified translations
• Interviews conducted in local languages
and moderated by experienced psychologists
• Realistic sample size provided at time of study bid
• Deliverables in English and/or in local languages
PATIENT CHART REVIEWS
• Physician recruitment and/or Site enrollment
• Patient selection performed by the physicians
• eCRF or paper-based form
• CRF in English or in local languages
(High quality and certified translations)
• Advanced data checks: online controls to track
possible mistake and help the respondent correct
data entered, checking of data after the end of the
• Double entry module for data checking possible
• Realistic sample size provided at time of study bid
• Oversampling to guaranty final sample size after
DATA COLLECTION FOR
• Health Economics
• Patient Registries
• Epidemiology Studies
• Patient-Reported Outcomes
• Health Preference Assessment / Discrete Choice
• Product Utilization Studies
• QoL and Patients’ Burden of Disease and Treatment
• Desk research, Literature review
STUDY MATERIAL DESIGN
Case Report Form
Translation & linguistic validation.
SUBMISSION TO IRB & ETHICS COMMITTEE
Contract Agreement design
EC or IRB submission
Identification of specific EC material, EC contacts and forms
Collection of the specific fees to be paid
(EC, start-up, hospital overhead)
Preparation of the EC submission package with the PI (if required)
Negotiation of the contract with Site Legal team.
OF ONLINE SURVEY, E-DCF
Multiple online data controls
Discrete Choice Experiment
Analytical reports (global, country)
De-identified validated database
Advanced statistical analysis (modeling, forecasting, etc.)
Scientific articles & submission to journals.
Qualitative interviewing using advanced techniques (cognitive, TTO, item generation, etc.)
Advanced Quality Check
Recruitment of Sites, PIs and Investigators.
ADVERSE EVENT REPORTING
Daily AER or end of DC
All staff trained and certified.
Your projects are always challenging, and global/local EC requirements often impose constraints affecting study feasibility (collect patient informed consent, pre-recruitment, delete questions, higher level of patient data de-identification, etc.): working with you is an opportunity for AplusA staff to demonstrate how solution-oriented we are to match both your objectives and constraints, and to provide you not just with data but also insights.
Prompt & rapid offers
Reply to your request for a bid in 2-3 business days.
A single point of contact
We coordinate sub-contractors & suppliers and guaranty high quality data.
Adaptable to your process
We take the lead from A to Z or manage data collection and data delivery.
We partner with your preferred suppliers or with our suppliers.
Fully dedicated expert team
Capitalize on knowledge and know-how of AplusA experts and teams to add value to the projects.
Capability to interview all targets
Physician recruitment & Site enrollment
• Via emailing
• Via phone call
• Via healthcare specialized panels/professional directories
We do not limit our recruitment efforts to database but are able to do free-found recruitment by calling the hospitals, etc. through snowballing (peers’ recommendations), etc.
Site recruitment through CRA
Physician diploma validation
• Through physicians for a confirmed diagnosis
• Through patient associations/ patient advocacy groups
• Through specialized patient panels
FEASIBILITY STUDY AND PILOT PHASE
• To assess site/physician ability to participate in the
study: number of eligible patients, site or contracting
constraints, access to required data
• To test and validate study material prior to the start
of data collection.
• After the soft launch: to check that data are captured
and saved accurately in the dataset
• At any time during the data collection for interim
A SECURED & USER-FRIENDLY PORTAL
Programming and hosting
• In-house programming and hosting on secured servers located in France.
• Multiple online controls of data captured via comprehensive error messages.
• Possibility to interrupt and re-access where they left off.
All changes made during quality control of the database are documented, traceable & stored.
Final dataset at the end of data collection
Strict monitoring of all completed interviews in 2 steps:
• Each interview is reviewed for illogical or unusual data.
• If data are determined to be illogical or unusual data, physicians are recalled to check/correct their answers BUT when in doubt or the respondent is unreachable, the interview is replaced.
Double entry module for patient chart studies available.
WE COMPLY WITH THE BEST INDUSTRY PRACTICES
We recognize the importance of a stringent but fluid compliance to international and local regulations. Our process is continuously adjusted according to the most up-to-date legal and ethical requirements; and staff members receive the necessary training under the supervision of the quality management team.
BEST MARKETING RESEARCH PRACTICE
Adverse Event Reporting
AplusA’s Standard process
Quality Management System
AplusA’s AER process:
100% internal staff training
100% fieldwork partners training
Secured access to data
Business continuity plan
Backup and restore process
Code of Conduct,
Respondent rights, Anti-bribery
US & french Sunshine Act (loi Bertrand)
GDPR and CNIL
Institutional review board (IRB) and ethics committee submission
PROJECT MANAGEMENT TEAM
APLUSA REAL WORLD TEAM Non-Interventional studies
Laëtitia Paradisi, PharmD
Senior Project Manager
OUR OTHER EXPERTS
• Data collection & recruiting team
• Qualitative experts
• Local partners for recruitment
• Translators and linguistic validation
• MDs, PharmDs, Mscs, MAs
• KOLs, Principal Investigators
Legal and Compliance Experts
• Life Science Lawyers
• CIL (for France)