AplusA Real World:
Non-Interventional
Studies

AplusA Real World collects real-world patient data.

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.

As healthcare moves in a value-based and patient-centric direction, patient chart based data inform practice and monitor trends and patient outcomes.

AplusA Real World:
Non-Interventional
Studies

AplusA Real World collects real-world patient data.

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.

As healthcare moves in a value-based and patient-centric direction, patient chart based data inform practice and monitor trends and patient outcomes.

Prospective & retrospective collection
of real world data

Qualitative

  • IDIs
  • Focus groups – mini groups
  • Advanced cognitive techniques

Quantitative

  • Patient charts studies
  • Surveys
  • Online, mobile, mail, telephone

Prospective & retrospective collection of real world data

Qualitative

  • IDIs
  • Focus groups – mini groups
  • Advanced cognitive techniques

Quantitative

  • Patient charts studies
  • Surveys
  • Online, mobile, mail, telephone

Key numbers
from AplusA Real World

PATIENTS & CAREGIVERS PER YEAR

PATIENTS CHARTS PER YEAR

AplusA Real World Services

The AplusA Real World team support clients by gathering real-world data insights. 

5

1 - Study Material Design

  • Methodology Design
  • Protocol Writing
  • Case Report Form
  • Questionnaire
  • Interview guide
  • Informed consent
  • Translation & linguistic validation.
5

2 - Submission to IRB and Ethics Committee

Based on your study specifications and local regulations, our experts and legal teams provide accurate and specific guidance on the local requirements needed to obtain EC/IRB approvals. Our worldwide network of local CRAs enable us to perform submissions to EC/IRB in more than 30 countries. Local CRAs manage all activities required within the process from site enrollment and feasibility assessment, to EC approvals, contracting and site monitoring.

  • 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.
5

3 - Advanced Programming of Online Surveys and E-DCFs

  • Multiple online data controls
  • Discrete choice experiment
  • Best to worst scaling
  • Segmentation
5

4 - FEASIBILITY STUDY AND PILOT PHASE

  • Assess site/physician ability to participate in a study (number of eligible patients, site or contracting constraints, access to required data)
  • Test and validate study material prior to the start of data collection
5

5 - Interim Datasets

  • After the soft launch we deliver interim datasets to check that the data is being captured and saved correctly
  • Interim datasets at any time during the data collection for interim outcomes
5

6 - Data Collection, Analysis and Reporting

  • Analytical reports (global, country)
  • De-identified validated database
  • Advanced statistical analysis (modeling, forecasting, etc.) 
  • Scientific articles and submission to journals
5

7 - Adverse Event Reporting

  • Daily AER or end of DC
  • All staff trained and certified

AplusA Real World Services

The AplusA Real World team support clients by gathering real-world data insights. 

5

Study Material Design

  • Methodology Design
  • Protocol Writing
  • Case Report Form
  • Questionnaire
  • Interview guide
  • Informed consent
  • Translation & linguistic validation.
5

Submission to IRB and Ethics Committee

Based on your study specifications and local regulations, our experts and legal teams provide accurate and specific guidance on the local requirements needed to obtain EC/IRB approvals. Our worldwide network of local CRAs enable us to perform submissions to EC/IRB in more than 30 countries. Local CRAs manage all activities required within the process from site enrollment and feasibility assessment, to EC approvals, contracting and site monitoring.
• 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.

5

Advanced Programming of Online Surveys and E-DCFs

  • Multiple online data controls
  • Discrete choice experiment
  • Best to worst scaling
  • Segmentation
5

FEASIBILITY STUDY AND PILOT PHASE

  • Assess site/physician ability to participate in a study (number of eligible patients, site or contracting constraints, access to required data)
  • Test and validate study material prior to the start of data collection
5

Interim Datasets

  • After the soft launch we deliver interim datasets to check that the data is being captured and saved correctly
  • Interim datasets at any time during the data collection for interim outcomes
5

Data Collection, Analysis and Reporting

  • Analytical reports (global, country)
  • De-identified validated database
  • Advanced statistical analysis (modeling, forecasting, etc.) 
  • Scientific articles and submission to journals
5

Adverse Event Reporting

  • Daily AER or end of DC
  • All staff trained and certified

Global and/or 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.).

The AplusA Real World team are highly experienced in working within these contstraints to deliver the insights and data to meet your project’s needs and objectives.

Patient Centered Outcomes

  • Wide scope of patients and caregivers including chronic diseases and 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 (certified translations)
  • Advanced data checks: online controls to track possible mistakes 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 in many areas

  • 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

Let’s talk!

Looking for more information about AplusA Real World?
Whether you’d like to discuss a specific project or find out more information about what we do, the Real World team would be delighted to speak with you.