Resources and expertise that help solve the unique challenges of rare disease research

Partnering with you to make your next gastrointestinal disease study a success

Mapi Group is among the leading providers of Patient-Centered Research services, supporting life science companies in the commercialization and post-approval research of gastrointestinal (GI) treatments. With decades of experience and therapeutic area expertise in post-approval studies, registries, and Risk Management programs, Mapi is the clear choice in supporting GI indication research.

We are the world’s leading supplier of post-authorisation registries for drugs treating autoimmune-related gastroenterology diseases, especially Crohn’s Disease and Ulcerative Colitis. We have conducted six global PASS studies, between five to ten thousand patients each, providing their sponsors with exceptional data about the efficacy and safety of new monoclonals.

Nobody in the industry comes close to our level of experience with registries within the GI segment. We work with you from the very beginning of your project to maximize efficiency and ease the burden of taking your project to market. Our people, our knowledge, and our systems ensure that your GI disease study generates meaningful data and contributes to the success of your product.

Our Expertise

The gastroenterological segment is complex, and competition is stiff for those aiming to advance healthcare options for sufferers of chronic GI discomfort and disease. To successfully get products from “molecule to market,” you need the benefits of a knowledgeable support network. We provide our partners with therapeutic expertise in GI studies to help you balance time, cost, and risk at every step, maximizing the marketability of your GI therapy.

Mapi offers deep knowledge of operational, regulatory, market access, and commercial global pathways to help you optimize every element of your program. Our capabilities include the design and conduct of observational studies globally, as well as extensive experience in the management of a variety of post-marketing studies involving GI diseases.

Mapi adds value throughout your product’s lifecycle, helping to reduce study cycle times, optimize costs, and ultimately help increase your chances of regulatory and market success. Our focus on real world research provides a significant advantage in operational efficiency, which translates into cost-effectiveness.

Your Global Partner
Leveraging global capabilities and proven expertise, Mapi brings current and relevant experience to the task of managing GI studies globally.

We offer exceptional knowledge of the global clinical research environments, particularly for the gastrointestinal therapeutic area. With headquarters in the US and Europe, and offices around the world, our skilled project managers and directors provide a deep knowledge of the global research environment to help you optimize your likelihood of marketplace success.

We possess extensive experience in the conduct of late phase studies globally, as well as in the management of a variety of global post-marketing studies. With 40 years of late phase experience, Mapi has the right combination of experience and expertise to conduct your registry and bring it to a successful conclusion.

Our Services

Mapi has a distinct advantage over other providers when it comes to helping clients conduct successful GI studies. Our forty-year history of developing, managing, validating, and leveraging clinical assessments to support and inform the decision-making of regulators, payers, and physicians provides the foundation for our GI patient-population research.

Mapi’s global leadership focus is patient-centered, and our experienced team can support every stage of the development process to offer an unparalleled range of services and expertise.

Our Team

Coordination and management by an experienced project team is essential to the successful conduct of any life science project, particularly in the GI space. As part of our mission to improve GI healthcare, Mapi brings together multidisciplinary specialists from across the globe to improve GI product development and meet your project’s objectives.

With decades of experience and training, our teams provide tremendous value in the planning and operational stages of any project. We select and train teams to be efficient and cohesive, and function as an integral part of your teams, sharing the same goals and accomplishing the following:

  • Maximizing communication efficiency
  • Minimizing start-up time
  • Reducing management investment
  • Increasing level of confidence in successful delivery
  • Controlling costs through process efficiency
  • Executing in full compliance with ICH and GPP standards

Mapi teams have long-standing and strong working relationships within the industry, which enables us to proactively meet our clients’ needs based on our understanding of the unique challenges of GI research.

Our Experience

Our team has extensive experience in the gastroenterological therapeutic area. With this experience, we are able to understand and anticipate your expectations. Over the past ten years, we have implemented twenty studies in the gastroenterology therapeutic area, covering various GI diseases such as GERD, Crohn’s Disease, and Ulcerative Colitis. Consequently, we are well informed on the patient population, the physician population, and on the structure of the healthcare systems of each country for those specific patients.

Constipation

  • Development and validation of a multi-attribute system for patient assessment of constipation
  • Instrument development/assessment strategy in chronic idiopathic constipation
  • Instrument development/assessment strategy in functional constipation
  • Validation of the diarrhea symptom assessment measure
  • Budget impact model in Opioid-Induced Constipation (OIC)
  • Review of patient diaries and PRO questionnaires for evaluating OIC
  • Patient interviews, endpoint model, conceptual framework in OIC
  • Instrument development in OIC
  • Cognitive debriefing of quality of life questionnaire and patient assessment of symptoms in OIC
  • Development of a PRO strategy for pediatric Chronic Constipation (CC)
  • Development of a manuscript on the PAC-QoL results (Quality of Life in Constipation)
  • Development of a manuscript on PRO in pediatric constipation
  • Development of symptom and HRQL PRO instruments for pediatric patients with CC
  • Advisory Board on the PRO strategy for phase III program for treatment in OIC
  • Cognitive debriefing of a PRO measure of paediatric CC and IBS-C
  • Interviews of patients completing clinical trial in chronic constipation and IBS-C to understand their experiences
  • Network meta-analysis of treatments for Irritable Bowel Syndrome with constipation and chronic constipation: abstracts and publications

Inflammatory Bowel Disease

Our experience in long-term registries of patients using biological agents for treatment of UC and Crohn’s Disease (CD) tells us that a successful IBD study balances the need for data with the desire to minimize site and patient burden.

Mapi has extensive global experience in IBD indications—including study services encompassing more than 20,500 patients and 1,400 sites, covering 70 countries—and we can provide essential assistance with the successful development and management of your study/project.

Further, we have conducted numerous long-term studies focused on patients with inflammatory bowel diseases to address comparative effectiveness, safety, and risk management.

ibdchart

Because we are very familiar with the leading investigators of this therapeutic area, our teams thoroughly understand the challenges to product development, and we are confident our skills and our understanding of your needs are unmatched by our competition.

Previous IBD Studies

DTP Crohn’s Disease Study

  • Study Type: direct-to-Patient, patient management
  • Pathology/Indication: Crohn’s disease
  • Sites: 330
  • Patients: 330
  • Countries: 25
  • Services Provided: patient direct contact

On-site Crohn’s Disease Study

  • Study Type: PASS, Registry, Product
  • Pathology/Indication: Crohn’s disease
  • Sites: 200
  • Patients: 5,000
  • Countries: 8
  • Services Provided: on-site monitoring; site

DEVELOP Rave Migration

  • Study Type: PASS, registry, disease
  • Pathology/Indication: Crohn’s disease
  • Sites: 125
  • Patients: 6,000
  • Countries: 13
  • Services Provided: data management, project

Ulcerative Colitis Study

  • Study Type: observational, PASS, registry, product
  • Pathology/Indication: Ulcerative Colitis
  • Sites: 750
  • Patients: 8,250
  • Countries: 28
  • Services Provided: data management, internet portal, legal/site contracts, medical writing, on-site monitoring, project management, regulatory document collection, safety management, site
    management/regulatory, site recruitment, statistical analysis

Crohn’s/UC Global Study

  • Study Type: PASS, registry, product
  • Pathology/Indication: Crohn’s disease/Ulcerative Colitis
  • Sites: 350
  • Patients: 5000
  • Countries: 22
  • Services Provided: data management, help desk, hosting, internet portal, legal/site contracts, medical coding, project management, regulatory document collection, safety management, site management/regulatory, site recruitment, statistical analysis

Retro/Observational Study to Understand Therapeutic Patterns & Costs Associated with Inadequate Response to Anti-TNFsStudy Type: Observational; Retrospective: Chart Review

  • Pathology/Indication: Crohn’s disease/Ulcerative Colitis
  • Sites: 82
  • Patients: 1316
  • Countries: 6
  • Services Provided: data management, help desk, legal/site contracts, medical writing, on-site monitoring, project management, protocol development, regulatory document collection, site management/regulatory, site recruitment, statistical analysis

Current IBD Studies

UC/CD PASS Study
Mapi is currently conducting the set-up of a large PASS study in 20 countries in North America, Europe, and Australia. The study will be conducted in 350 sites to recruit 5,000 patients in both UC and CD. Patient recruitment will last five years and the patient follow up will be two years minimum so the full study duration is seven years. It is conducted using EDC system and involves Direct-To-Patient Contact and the application of QoL questionnaires, both by self and phone administration.

Crohn’s Disease Registry
Mapi is currently conducting a multicenter global registry of patients with CD. The primary objective of the registry is to evaluate the long-term safety of the sponsor product in moderate to severely active UC adult patients, (18 years of age or older) who are treated as recommended in the local product label. The secondary objective is to evaluate long-term effectiveness of the product in this patient population who have had an inadequate response to conventional therapy, and who are treated as recommended in the local product label.

This registry is being conducted across approximately 500 sites representing gastroenterologists who will prescribe the product or IMM therapy for patients with moderately to severely active UC in countries where market authorization has been obtained.

The number of subjects to be enrolled is 8,250 (approximately 5,500 patients prescribed the sponsor product), with or without concurrent IMM therapy, and approximately 2,750 patients prescribed IMM with no use of the sponsor product or similar biologic.

Pediatric Crohn’s Disease Registry
Mapi is currently conducting and monitoring a global, multicenter, non-interventional registry of pediatric patients with moderately to severely active CD treated in a routine clinical setting with immunosuppressant non-biologic therapy. Pediatric patients meeting entry criteria will be enrolled. All patients who consent to take part in the registry will be followed for up to 10 years. This registry will have 24 countries primarily in Europe, North America, and Australia. It is designed to evaluate long-term safety and effectiveness in patients between the ages of 6 and 17 years. The registry plans to enroll over 150 sites and 1,300 patients.

Additional IBD Experience

  • Retrospective observational study to describe treatment patterns and healthcare resource utilization associated with anti-Tumor Necrosis Factor (TNF) therapy in patients diagnosed with Crohn’s disease or ulcerative colitis
  • Literature review of quality of life in Crohn’s disease
  • Literature review of pharmaco-economics in Crohn’s disease
  • Database analysis in Crohn’s disease and ulcerative colitis
  • Early phase Markov model in Crohn’s disease (pricing simulation)
  • Psychometric validation of a quality of life questionnaire in Crohn’s disease
  • Submission to Scottish Medicines Consortium for treatment for ulcerative colitis
  • Development and validation of satisfaction with biological treatment questionnaire in Crohn’s disease
  • Manuscript on the development of a questionnaire on satisfaction with biological treatment in Crohn’s disease
  • PRO gap analysis and PRO dossier development in ulcerative colitis and Crohn’s disease
  • Consultancy on SPACE questionnaire in Crohn’s disease
  • Psychometric validation of a questionnaire in Crohn’s disease in Canada, Portugal, and Greece
  • Study concept for an observational study in severe Crohn’s disease using a patient satisfaction questionnaire
  • Literature review and recommendations for treatment in Crohn’s disease
  • PRO review for Crohn’s disease
  • Development on validation of a questionnaire measuring patients satisfaction with anti-TNF in Crohn’s disease
  • Observational study to measure patient motivation to pursue anti-TNF treatment in severe Crohn’s disease
  • Observational study in severe Crohn’s disease using a patient satisfaction questionnaire: analysis reporting and public
  • Network Meta-Analysis of Competing Interventions for Ulcerative Colitis: Feasibility Assessment & Analysis
  • Comparative efficacy and tolerability of treatment in Crohn’s disease: Development of a Technical Report
  • Validation of satisfaction questionnaire in Crohn’s disease: additional analysis for responses to reviewers’ comments

Irritable Bowel Syndrome

  • Review of FDA correspondence and recommendations for PRO measurement strategy in IBS-D
  • Instrument development/assessment strategy in IBS
  • Prospective, naturalistic trial in IBS: literature review, protocol, CRA/investigator training, analysis plan, and analysis
  • Development and validation of a primary endpoint to support an indication in IBS-D
  • Literature review of PROs and endpoints in IBS
  • Design, conduct, and analysis of focus groups in IBS
  • Analysis and a report for IBS-C interviews (to include evidence of saturation)
  • Development of a PRO strategy for pediatric IBS with constipation
  • Development of a manuscript on PRO in pediatric IBS
  • Consulting for PRO for treatment in patients with IBS
  • Development of symptom and HRQL PRO instruments for pediatric patients with IBS-C
  • Development of a PRO questionnaire to assess symptoms and burden of IBS in different languages (France, UK, and Spain)
  • Development of a PRO Dossier in IBS-C
  • Communications in pediatric IBS-C
  • Psychometric validation for newly developed PRO in IBS-D
  • Cognitive debriefing of a PRO measure of pediatric chronic constipation and IBS-C
  • Interviews of patients completing clinical trial in chronic constipation and IBS-C to understand their experiences
  • Psychometric validation for a newly-developed PRO instrument in IBS-D
  • Development of PRO questionnaire in three languages in IBS
  • Development of PRO questionnaire to assess symptoms and their burden in healthy subjects and IBS patients: France, UK, and Spain
  • Network Meta-Analysis of treatments for Irritable Bowel Syndrome with constipation and chronic constipation: abstracts and publications

Upper GI Disorders

  • Instrument development/assessment strategy in upper gastrointestinal disorders
  • Development and validation of a symptom checklist and diagnostic tool for patient management in upper GI disorders
  • Development of a symptom checklist in upper GI disorders
  • Development of a short form questionnaire in gastro-esophageal reflux disease
  • Development of a PRO questionnaire to assess symptoms and burden of dyspepsia in different languages (France, UK, and Spain)
  • Consultancy on PRO questionnaire in dyspepsia

GERD (Gastroesopageal Reflux Disease)

Mapi provides extensive translation, linguistic, and ePRO-validation services for clients working in the GERD segment. Our team can consult and further aid product development, as we did in the case of the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) and PAGI-Symptoms Severity Index (PAGI-Sym).

Over the past few years Mapi has conducted seven studies in GERD in Europe. Our non-profit organization Mapi Research Trust manages distribution, translation, licensing, and permission for several GI questionnaires specifically related to GERD:

gerdchart

Other Gastrointestinal Disorders

  • Observational study of colostomy patients: study design, data collection, observational study, and report
  • Foundation research in digestive problems
  • Development of a briefing packet for an FDA Type C meeting for a primary endpoint in functional dyspepsia
  • Clinical trial endpoint review, recommendations, and FDA PRO submission package in hereditary angioedema
  • Hereditary angioedema ad hoc strategic consulting
  • Interviews for language validation of the Ascites Impact Questionnaire
  • Market access evidence assessment for a new orphan drug for short bowel syndrome
  • Review of a protocol and protocol amendment for a phase II gastroparesis study which includes the CGSI as a primary endpoint
  • Burden of illness literature review in opioid-related bowel dysfunction
  • Literature review of the management of post-operative ileus in Europe
  • Burden of illness study of post-operative ileus in Europe
  • Development and validation of a PRO measure in pediatric patients with eosinophilic esophagitis
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Endpoint review and recommendations in hereditary angioedema
  • Update to FDA submission package in hereditary angioedema
  • Cognitive debrie ng of a PRO questionnaire in hereditary angioedema
  • Analysis of qualitative data to create a symptom measure in eosinophilic esophagitis and cognitive debriefing interviews
  • Cognitive debriefing of a symptom measure of gastroparesis in diabetics
  • Conceptual model of the impact in the elderly of Clostridium difficile infection
  • Communication on Clostridium difficile infections: publication and posters
  • Comprehension testing with eosinophilic esophagitis patients

Our Resources

Mapi Research Trust has over 25 years of experience distributing questionnaires in the field of Patient-Centered Outcomes. For over two decades we have built up a catalog that today curates information on over 4,000 questionnaires and distributes more than 200.

Selected Questionnaires

Aronchick Scale: Aronchick Scale
BDI-TDI: Baseline and Transition Dyspnea Indexes
BSF Scale: Bristol Stool Form Scale
CD-QOL: Celiac Disease Quality of Life Measure
CDAI: Crohn’s Disease Activity Index
CDEIS: Crohn’s Disease Endoscopic Index of Severity
CDQ: Celiac Disease Questionnaire
CFQ: Cystic Fibrosis Questionnaire
CFQ-R: Cystic Fibrosis Questionnaire-Revised
CFRSD: Cystic Fibrosis Respiratory Symptom Diary
CLDQ: Chronic Liver Disease Questionnaire
CMCQ: Comorbid Medical Conditions Questionnaire
DHSI: Digestive Health Status Instrument
DSIQ: Digestive Symptoms and Impact Questionnaire
EORTC QLQ-CR29: EORTC Quality of Life Questionnaire - Colorectal Cancer Module
EORTC QLQ-GINET21: EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module
EORTC QLQ-HCC18: EORTC Quality of Life Questionnaire - Hepatocellular Carcinoma / Primary Liver Cancer Module
EORTC QLQ-LMC21: EORTC Quality of Life Questionnaire - Liver Metastases Colorectal Module
EORTC QLQ-OES18: EORTC Quality of Life Questionnaire - Oesophageal Cancer Module
EORTC QLQ-OG25: EORTC Quality of Life Questionnaire - Oesophago-Gastric Module
EORTC QLQ-STO22: EORTC Quality of Life Questionnaire - Gastric Cancer Module
FACT-Hep: Functional Assessment of Cancer Therapy - Hepatobiliary Cancer
FBDSI: Functional Bowel Disorder Severity Index
FDDQL: Quality of Life Questionnaire for Functional Digestive Disorders
FIQL: Fecal Incontinence Quality of Life scale
FISI: Fecal Incontinence Severity Index
GCSI: Gastroparesis Cardinal Symptom Index
GERD-HRQL: Gastroesophageal Reflux Disease Health Related Quality of Life scale
GIQLI: Gastrointestinal Quality of Life index
GSAS: Gastroesophageal Reflux Disease Symptom Assessment Scale
GSFQ: GERD Symptom Frequency Questionnaire
GSRS: Gastrointestinal Symptom Rating Scale - original interviewer-administered version
GSRS-self: Gastrointestinal Symptom Rating Scale - self-administered version
HAI: Knodell Score or Histology Activity Index
HBQOL©: Heartburn-Specific Quality of Life Instrument
HPN-QoL: Home Parenteral Nutrition - Quality of Life
IBDQ: Inflammatory Bowel Disease Questionnaire
IBDQOL: Inflammatory Bowel Disease Quality of Life Questionnaire
IBS-36: IBS-36
IBS-QOL: Irritable Bowel Syndrome - Quality Of Life
IBS-SSS: Irritable Bowel Syndrome Severity Scoring System
IMPACT III: IMPACT III
Ishak Score: Ishak Score
LDQOL: Liver Disease Quality of Life Questionnaire
LDSI: Liver Disease Symptom Index
NBD score: Neurogenic Bowel Dysfunction score
NDI / NDI-SF: Nepean Dyspepsia Index
PAGI-QOL: Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life
PAGI-SYM: Patient Assessment of Gastrointestinal Disorders Symptom Severity Index
PCDAI: Pediatric Crohn Disease Activity Index
PedsQL Eosinophilic Esophagitis Module: Pediatric Quality of Life Inventory Eosinophilic Esophagitis Module
PedsQL Eosinophilic Esophagitis Symptoms Scales: Pediatric Quality of Life Inventory? Eosinophilic Esophagitis Symptoms Scales
PedsQL Gastrointestinal Symptoms Module: Pediatric Quality of Life Inventory? Gastrointestinal Symptoms Module
PEESS v2.0: Pediatric Eosinophilic Esophagitis Symptom Severity Module, version 2.0
PUCAI: Pediatric Ulcerative Colitis Activity Index
QLI-CP: Quality of Life Index for Colostomy Patients
QOLRAD: Quality Of Life in Reflux And Dyspepsia
Reflux-Qual: Quality of Life Questionnaire in Gastroesophageal Reflux
RFIPC: Rating Form of IBD Patient Concerns
RFIS: Revised Faecal Incontinence Scale
RPSQ: Recent Physical Symptoms Questionnaire
SAC BDI-TDI: Self-administered Computerized version of the BDI-TDI
SAT-37: Satisfaction with Care Scale
SPACE-Q: Satisfaction of Patients with Crohn’s disease
SWAL-QOL: Swallowing Quality of Life questionnaire
TSQ-G: Treatment Satisfaction Questionnaire for Gastroesophageal reflux disease
UC-CD Health Status: Ulcerative Colitis and Crohn’s Disease Health Status Scales
VSS: Vesikari Clinical Severity Scoring System

Our Relevant Publications

Relevant Publications

  • Arnould B, Fofana F, Gilet H, Colombel JF, Faure P, Hagege H, et al. Finalization and psychometric validation of a new questionnaire measuring patient satisfaction with anti-TNF treatments in severe Crohn’s disease. 2012.
  • Marant C, Arnould B, Marrel A, Spizak C, Colombel JF, Faure P, Hagege H, Lemann M, Nahon S, Tucat G, Vandromme L, Thibout E, Goldfarb G. Assessing patients’ satisfaction with anti-TNF alpha treatment in Crohn’s disease: qualitative steps of the development of a new questionnaire. Clin Exp Gastroenterol. 2011;4:173-180.
  • Dubois D, Gilet H, Viala-Danten M, Tack J. Psychometric performance and clinical meaningfulness of the Patient Assessment of Constipation-Quality of Life questionnaire in prucalopride (RESOLOR) trials for chronic constipation. Neurogastroenterol Motil. 2010;22:54-63.
  • Patrick D, Acquadro C, Conway K. Expression of Gastrointestinal Symptoms and Their Impact: Similarities and Differences Across Countries Patient Reported Outcomes Newsletter. Spring Issue 2011; 45, p13-16.
  • Conway K, Méar I, Irvine J. Conceptual definition of PRO measures: a case study with the Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ). Quality of Life Research. October 2010; 19(supp.1), p114-218/1604. ISOQOL 17th Annual Conference, London–United Kingdom, October 2010. Nominated for a 2010 Best Poster Award.
  • Arbuckle, R., Lewis, B.E., Carson, R., Abetz, L., Johnston, J.M. Child and parent reports of symptoms of irritable bowel syndrome with constipation (IBS-C): results of qualitative interviews. ISPOR 13th Annual European Congress, Prague, Czech Republic, 6-9 November 2010.
  • Bending MW, Trueman P, Lowson KV, Pilgrim H, Tappenden P, Chilcott J, Tappenden J. Estimating the direct costs of bowel cancer services provided by the National Health Service in England. Int J Technol.Assess.Health Care 26 (4):362-369, 2010.
  • Carson R, Arbuckle R, Abetz L, et al. The Symptoms of Irritable Bowel Syndrome with Constipation (IBS-C): Results of Qualitative Interviews with Children and their Parents. ISOQOL 17th Annual Conference, London, UK, 27-30 October 2010.
  • Muller S, Jan Irvine E, Gathany T. A. Linguistic Validation of the Inflammatory Bowel Disease Questionnaire (IBDQ) for use in International Studies. Presented at ISPOR 13th Annual International Meeting, Toronto, Ontario - Canada, May 3-7, 2008.