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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.

Canada

USA

Argentina

Brasil

Chile

Columbia

Mexico 

Austria

Belgium

Denmark

Finland

France

Germany

Italy

Luxemburg

Netherlands

Norway

Portugal

Spain

Sweden

Switzerland

Turkey

UK

Israel

KSA 

Kuwait

UAE

Australia

China

South Korea

EXPERT IN COLLECTING REAL WORLD DATA

Prospective & retrospective

Qualitative 

• IDIs

• Focus groups - Mini Groups

• Advanced cognitive techniques

Quantitative

• Patient charts studies

•  Surveys

•  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 

data collection

• Double entry module for data checking possible

• Realistic sample size provided at time of study bid

• Oversampling to guaranty final sample size after 

data checking

DATA COLLECTION FOR

• Health Economics 

• Patient Registries

• Epidemiology Studies

• Patient-Reported Outcomes

• Health Preference Assessment / Discrete Choice   

   Experiment

• Product Utilization Studies

• QoL and Patients’ Burden of Disease and Treatment

• Desk research, Literature review

 
STUDY MATERIAL DESIGN

Methodology Design

Protocol Writing

Case Report Form

Questionnaire

Interview guide

Informed consent

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.

ADVANCED PROGRAMMING
OF ONLINE SURVEY, E-DCF

Multiple online data controls

Discrete Choice Experiment

Best-Worst Scaling

Segmentation, etc.

DELIVERABLES 
FROM DATABASE 
TO PUBLICATION

Analytical reports (global, country)

De-identified validated database

Advanced statistical analysis (modeling, forecasting, etc.) 

Scientific articles & submission to journals.

Pilot phase

Qualitative interviewing using advanced techniques (cognitive, TTO, item generation, etc.)

Advanced Quality Check

Recruitment of Sites, PIs and Investigators.

DATA COLLECTION
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.

 

RECRUITMENT PROCESS

Capability to interview all targets

• Physicians

• Surgeons

• KOLs

• Nurses

• Payors

• Caregivers

• Patients

Physician recruitment & Site enrollment

Patient recruitment

Direct-to-investigator recruitment

 

• 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 

or treatment

• 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.

INTERIM DATASET

• 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 

outcomes

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
QUALITY
PHARMACO-VIGILANCE
SAFETY
Process, Training,
Control
Adverse Event Reporting
Data protection,
Data preservation
  • Quality Department

  • AplusA’s Standard process

  • Quality Management System

  • Client Satisfaction

  • Continuous improvement

  • AplusA’s AER process:

  • Continuously updated

  • 100% internal staff training

  • 100% fieldwork partners training

  • Secured access to data

  • Confidentiality clause

  • Business continuity plan

  • Backup and restore process

COMPLIANCE
Code of Conduct, 
Respondent rights, Anti-bribery
  • US & french Sunshine Act (loi Bertrand)

  • GDPR and CNIL

  • Institutional review board (IRB) and ethics committee submission

  • ESOMAR

  • EphMRA

  • Intellus

  • BVM

  • BHBIA

  • MRS

  • ASOCS

  • ISPOR

 
PROJECT MANAGEMENT TEAM

APLUSA REAL WORLD TEAM Non-Interventional studies

 Delphine Schodts

Research Director

 Laëtitia Paradisi, PharmD

Senior Project Manager

 Anaïde Adamian

Project Manager

OUR OTHER EXPERTS

Technical Experts

 

• Data collection & recruiting team

• Biostatisticians

• Qualitative experts

• Local partners for recruitment

• CRAs

• Translators and linguistic validation

Medical Experts

 

• MDs, PharmDs, Mscs, MAs

• KOLs, Principal Investigators

Legal and Compliance Experts

 

• Life Science Lawyers

• CIL (for France)

 
LYON

 

AplusA Real World

2 avenue Lacassagne

69003 Lyon

France

+33 (0) 478 622 323