Request for Proposal

Submit your technology to Trials@Home

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Trials@Home (EU/EFPIA Innovative Medicines Initiative – Joint Undertaking (H2020-JTI-IMI2) Trials@Home grant n° 831458) aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe.

Request for Proposals (RfP)

In a collaboration with 31 international partners, the EU/IMI project called Trials@Home will check the feasibility of fully remote decentralised Clinical Trials (RDCTs). For the execution of these RDCTs, technologies are needed. Some of them are already familiar and/or contracted by the project partners, but other RDCT technologies are not and need to be introduced in this project and pilot study. We are looking for these technologies, and that’s why this Request for Proposals has been launched.

All the technologies are categorized in Basic Building Blocks (BBB) categories based on key functionalities within those building blocks, which are called activities. The scope of this RfP contains the following BBB’s / categories: Data Acquisition & Processing, Patient Engagement, Setup & Design, Closeout & Reporting, Operation & Coordination, Intervention & Follow-up and Recruit & Enroll. A description of these BBB’s and required technologies can be found in the ‘BBB profile’ tabs below or can be downloaded at the bottom of this page.

Basic Building Block Profile

Building Block: Setup and Design

Vision 

A compliant suite of access-controlled clinical and operational systems and document storage system which support site selection and initiation, GCP-compliant trial conduct, timely data entry and data integrity, and regulatory-filing documentation.  This suite drives inspection-readiness by funneling all required clinical oversight and study operational oversight to performance monitoring and operational analytics dashboards.

Systems must be configured to accommodate multiple, simultaneous end-users access and meet GDPR adherence requirements (e.g. 2-factor authentication), and data/records protection and retention.  System training, business continuity planning, user acceptance testing, automated functionality (e.g. auto-save; auto-log-off for idle periods), and tech support (“help desk”) will be prerequisites.

Included activities in the RFP

The following activities are included in the RFP:

  1. Operational feasibility and site selection
  2. Study branding
  3. IMP supply

OPERATIONAL FEASIBILITY AND SITE SELECTION

IMI/Trials@Home WP EAGLE has completed EU member country feasibility assessments.  The contracted vendor would be required to demonstrate an access-controlled, fully-functional, electronic site feasibility and site selection system (including but not limited to site outreach survey; investigator trial experience; enrollment estimates; contracting timelines estimation), as well as site initiation visit processes tracking.  These access-controlled systems must be accessible to the study operational oversight team.

The contracted vendor would be required to (1) conduct investigational site selection within IMI/Trials@Home selected countries for the classical clinical trial (CCT) arm and hybrid arm (Part A) portion of the study conduct and (2) pivot to recruitment of a purely decentralized arm, when necessary.  The contracted vendor would be expected to provide solutions for recruitment of the purely  decentralized arm that address current EU and local laws and regulations.  For all selected investigational sites, the contracted vendor should be able to demonstrate a compliant Investigational Site Master File system, rater qualification training and tracking system.

IMP SUPPLY

Decentralized trials arms face unique challenges regarding Direct-to-Participant (DtP) IMP shipments based upon current EU and local laws and regulations.  A contracted vendor must be able to demonstrate expertise executing the multi-step processes from (1) IRT/Drug Order to (2) Drug Delivery to Participants to (3) Drug Supply and Re-supply to (4) IMP returns to Central supplier assessment of drug compliance/exposure to (5) IMP destruction.

STUDY BRANDING

While listed as a functionality under Setup and Design BBB, study branding activities have been relegated to Patient Engagement BBB and Recruitment and Enrollment BBB.

Excluded activities from the RFP

The activities below are already covered by internal partners and excluded from the RFP:

  • Create participant and site education strategy
  • Site Start-up
  • Operational setup
  • Obtain Ethics & Regulatory approvals
  • Technology setup
  • Protocol development
  • Trial Registration
  • Online platform for study specific information (landing page and pre-screener) in desktop and mobile functionality

RFP – Knockout Criteria

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Operational feasibility and site selection

The technology will be rejected if:

  • Not able to demonstrate prior cases of at least two different clinical trials wherein Operational Feasibility and Site Selection systems were successful.
  • Not able to demonstrate prior cases of at least two different clinical trials wherein Operational Feasibility and Site Selection systems were successful and met GCP standards
  • Demonstration of above systems do not conform to reviewers’ expectations.

IMP supply

The technology will be rejected if:

  • Not able to demonstrate prior cases of at least two different clinical trials wherein IMP (from study drug assignment to drug destruction) and met EMA inspection standards.
  • Demonstration of IMP management systems do not conform to reviewers’ expectations.

 

Basic Building Block Profile

Building Block: Patient Recruitment & Enrollment

Vision

The Vision is based on 3 pillars:

1) Diabetes Carousel:
Is an online public platform to share information about diabetes, diabtes treatment, QoL, R&D processes and clinical trials for diabetes patients with patients and the wider public interested in diabetes. Website enables peer-to-peer interaction/communication between platform users to increase overall value and time spent on portal. Patients interested in joining RDCT will be informed about and invited to  the
2) My Patient/My Participant Portal:

Is an online platform hosting the landing page for patient digital pre-screening, digital recruitment and patient consenting into the RDCT. Through integration/intercation with EDC,eICF, tele-health, IRT/IWRS functionalities patients will be screened, consented recruited, treated and provided with study drug in both, remote and conventional arm.
3) Patient Recruitment Campaigns: digital and conventional

Included activities in the RFP

The following activities are included in the RFP:

  • Intelligent, interactive online platform (cloudbased) to host public information on diabetes
  • Peer-to-peer (patient-to-patient) Network
  • Ability to integrate App Solutions to ensure (depending on drug used) / ability to integrate data from smart cap devices tracking drug intake
  • Calendar integration to patients calendars / email inbox
  • Patient Recruitment Service Provider capable of both digital and non-digital Patient Recruitment specialized for diabetes/metabolic disorders.
    Core competencies:
    Interaction with diabetes patient communities, patient organisations, influencer outreach, providing access to MHR/EHR data; comfortable to use of Algorithms/AI to pre-identify patients through aggregated data/digital footprint (data purchasing diabetes books/accessories via Amazon and others Vendors interacting with pharmacies for information on prescribed diabetes drugs), SEO capabilities.

Excluded activities from the RFP

The activities below are already covered by internal partners and excluded from the RFP:

  • Differentiated access, functionality and content for patients, sponsor, CRO, investigator and site staff
  • Storage and Tracking of patient, site/investigator trainings and training materials
  • Patient engagement messaging as push out notifications
  • Distribution of study/IP-related patient information based on treatment arm (starter pack)
  • KPI/Metric tracking for use of Portal
  • eICF/ePRO functionality built into platform, video storage, information sharing and storage/ all ICF material needs to be stored/be available at all times during the study(for video)

RFP –  Knockout Criteria

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Peer-to-peer (patient-to-patient) Network

The technology will be rejected if:

  1. not GDPR compliant
  2. does not allow for Member Password and Login Identity
  3. does not provide membership eligibility check

Ability to integrate App Solutions to ensure (depending on drug used) / ability to integrate data from smart cap devices tracking drug intake

The technology will be rejected if:

  1. is not compatible for IMP used in PILOT

Calendar integration to patients calendars / email inbox

The technology will be rejected if:

  1. unable to integrate into iOS and Android and all current digital calendars
  2. unable to run on all current mobile as well as stationery devices

Patient Recruitment Service Provider capable of both  digital and non-digital Patient Recruitment specialized for diabetes/metabolic disorders

The technology will be rejected if:

  1. no previous experience/expertise in metabolic/diabetes (2 clinical trials)
  2. unable to demonstrate experience in a) digital
    b) conventional recruitment (at least 2 trials in relevant TA)
  3. unable to demonstrate experience/solutions for Behavioral Targeting/Retargeting, SEO, interaction with PAGs, influencers, POLs
  4. no P4P (pay for randomization)

Intelligent, interactive online platform (cloudbased) to host public information on diabetes research, treatment, therapy i.e. / providing link to clintrial.gov/pubmed etc.

The technology will be rejected if:

  1. not GDPR-compliant
  2. no integration with CTIS
  3. no interface to variety of external online platforms/systems

Graphs

Basic Building Block Profile

Building Block: Data Acquisition and Processing

Vision

The Data acquisition and Processing Basic Building Block contains activities related to data acquisition and processing of acquired data. The vision includes A) Data Collection, Management and Storage of different data sources to an internal infrastructure. This category includes activities in which all study data are stored and managed. Both patient’s and clinician’s perspectives are taken into consideration. Both general Data bases and devices/apps data categories are going to be integrated using appropriate well-defined Application Programming Interfaces (APIs), through secure user authentication/authorization (OAuth protocol) and will be stored in the internal interoperable repository infrastructure, ensuring that data privacy and quality standards are met. In the next phase comes the  B) Processing and Analysis, including activities in which data are checked, verified, transformed, and analysed. The RDCT concept is fully supported by service-oriented modular and remotely accessibly design: accessing data sources remotely through API web services and the infrastructure, as well as through data visualizations.

Activities

Included activities in the RFP

The following activities are included in the RFP:

Data Collection Middleware Technology

Μiddleware Technology system for active and passive data collection from data sources that will include monitoring devices, wearables, sensors and apps.

*Devices that might be used in the Pilot Study and will require such middleware:

  • Smart dosing insulin pen device
  • Continuous glucose monitoring device
  • Insulin titration support app
  • Adherence data capture app
  • etc

Data Transformation and Standardisation

Capabilities for converting data from one format or structure into another format or structure via a mixture of manual and automated steps.

Data Analysis

Statistical testing  for the protocol’s underlying hypotheses and Analytics capabilites also by making use of AI technology – retrospective, statistic analysis, clustering etc.

Excluded activities from the RFP

The activities below are already covered by internal partners and excluded from the RFP:

  • Management of study-generated data
  • Gathering and management of real-life data
  • Clinical data repository management
  • eCRF and system query design
  • Data reconciliation and Query management
  • Database Tools (e.g. lock)

RFP –  Knockout Criteria

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Data Collection Middleware Technology

The technology will be rejected if:

  • Data integration capabilities with Clinpal and other selected internal or external systems are missing (e.g. appropriate APIs)
  • Multiple data sources collection is not supported (monitoring devices, wearables, sensors and apps)
  • Not compliant with Data Quality and Data Privacy regulations

Data Transformation and Standardisation

The technology will be rejected if:

  • Data integration capabilities with Clinpal and other selected internal or external systems are missing (e.g. appropriate APIs)
  • Multiple data sources are not supported
  • Not compliant with Data Quality and Data Privacy regulations

Data Analysis

The technology will be rejected if

  • Data integration capabilities with other internal or external systems are missing (e.g. appropriate APIs)
  • Analytics capabilities, streaming analytics (e.g. for devices), “Business” Intelligence and Reporting capabilities are not present
  • Not compliant with Data Quality and Data Privacy regulations

Basic Building Block Profile

Building Block: Operation and Coordination

Vision 

Operation & Coordination BBB requires a clinical and operational platform that provides critical, real-time oversight dashboards throughout the conduct of the Pilot Study and is compliant with EU/ECC Global Data Protection Regulation (GDPR) requirements as well as local regulations and laws.   Oversight dashboards would be access controlled such that only study monitors, study/site auditors, EMA inspectors, and select clinical study team (CST) members would have an instantaneous, real-time overview of clinical site performance and study operations.  Oversight dashboards would be positioned to support study conduct, internal audits to promote inspection readiness, and EMA inspector visits.

Activities

Functional Requirements

Operation & Coordination BBB activities encompass the following functions:

Technical Requirements

Operation & Coordination BBB

Functional requirements and Technical requirements

Systems must be configured to accommodate multiple, simultaneous end-users’ access requirements (e.g. 2-factor authentication), and comply with protocol specified data/records protection and retention.  System training, business continuity planning, user acceptance testing, automated functionality (e.g. auto-save; auto-log-off for idle periods), and tech support (“help desk”) will be prerequisites.

To ensure participant data privacy, access-control systems for the integrated platform will only permit identity-authenticated end-users to access the systems and the dashboards drawing metrics from the systems complete all of the activities in the graphic above:

  • clinical oversight tasks are required to be available prior to study start to monitor timeliness of direct data entry, timeliness of upload of electronic source documents, visualize compliance with completion of participant-reported and clinician-reported data, visualize wearable device(s) data, and visualize vendor-specific data; each with intact audit trails).
  • study operational oversight tasks are required to be available prior to study start to comply with Study Monitoring Plan and complete site monitoring activities, protocol and GCP deviations identification and remediation, data management database maintenance (eCRF completion and cleaning; query issuance and time to query resolution, regulatory documents and other documents in TMF and GDMS).

Operation and coordination dashboards will be required to efficiently display all oversight metrics for internal auditors and EMA inspectors.  

Included activities in the RFP

The following activities are included in the RFP:

OPERATIONAL OVERSIGHT

Any contracted vendor providing oversight dashboard analytics must be provided controlled access to assess study recruitment data, EDC and eSource data, source document locator completeness data, study visit scheduling data, Trial Master File (TMF) completeness data, regulatory document submission packet components in the Global Document Management System (GDMS), and any other relevant operational data as frequently as specified by the study sponsor.

CLINICAL OVERSIGHT

Any contracted vendor providing clinical oversight dashboard analytics must be provided controlled access to assess protocol and GCP compliance data, study visit scheduling and completion data, data entry timeliness and completeness data, query issuance and resolution data, and regularly scheduled safety data updates (timestamped and auditable).

TELEMEDICINE VISIT MANAGEMENT

Any contracted vendor providing telemedicine visit management must provide high quality audiovisual interactions between study participants and multiple (potentially simultaneous) investigational site personnel (e.g. investigator, study nurse, pharmacist).  The vendor must provide efficient, scheduling solutions which account for participant and investigational site personnel availability.  Following each telemedicine visit completed, the vendor must elicit technology satisfaction responses from all parties included in the study visit to identify and quantify satisfactory and non-satisfactory aspects of the study visit.

STUDY OVERSIGHT

Excluded activities from the RFP

The activities below are already covered by internal partner and excluded from the RFP:

  • Performance monitoring
  • Document management
  • Home health visit management
  • Inspection facilitation
  • System approval facilitation
  • Regulatory management
  • Vendor management
  • Safety management
  • Manage protocol and GCP deviations
  • Creation of informed consent forms

RFP – Knockout Criteria

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Operational Analytics:

The technology will be rejected if:

1) Not able to demonstrate operational performance oversight dashboards functionality

Study Oversight:

The technology will be rejected if:

1) Not able to demonstrate operational performance oversight dashboards functionality

Basic Building Block Profile

Building Block: Close-out & Reporting

Vision

Close-out & Reporting is responsible for external communication and provides information on Trials@Home in form of study reports and scientific communications. Additionally, archiving of study-relevant data and decommissioning of study-related software and hardware is also in this BBB’s responsibility. A crucial prerequisite therefore is a solid data base. Based on the data, the compilation of final reports requires an envrionment which enables collaborative writing. The submission management should be integrated into the study’s digital platform to use the study’s central contact point for the publishing of study-relevant information.

One key aspect of Close-out & Reporting will be the publication of – optimally automatically generated – clinical and operational study reports based on the data provided by the shared digital platform and the clinical trials management system in form of raw data (for example eCRFs) or the TMF as well as clinical oversight data (provided by Operation & Coordination).

As a version-controlled repository for key documents, the global document management system is also potentially suited for the archiving task of Close-out & Reporting. It must, however, also be available beyound the end of the study.

Activities involved

Activities not relevant for the RFP are greyed out.


Included activities in the RFP:

The following activities are included in the RFP:

  • Archiving of study data
    • Clinical study data
    • Operational study data
    • Allow to exclude data (GDPR)
    • Data may have to be merged from several repositories
    • Options for cloud / physical archiving
    • Access mechanism to support remote audits
    • Automatic generation of overview/glossary file
  • Automatic generation of study reports
    • Provide templates that meet requirements for study reports
    • Defined interfaces to access relevant data in data repository
    • Provide reasonable overview prior to report generation
    • Allow to select/unselect data
    • Automatic compilation of clinical study reports
    • Automatic compilation of operational study reports

Excluded activities from the RFP

The activities below are already covered by internal partner and excluded from the RFP:

  • Decommissioning
  • Environment: collaborative report writing

RFP – Knockout Criteria

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Archiving of study data

The technology will be rejected if:

1) only providing one way of archiving (several options should be available/selectable)

Clinical study data

The technology will be rejected if:

1) it is not GDPR-compliant (e.g. needs to send data to unsecure servers)

Basic Building Block Profile

Building Block: Patient Engagement vision

Vision

The Patient Engagement vision is defined by three core engagement areas:

Essential Engagement Services:

The starting point in the patient engagement journey, essential engagement services should provide a foundation of knowledge to support the other core engagement areas.  Essential engagement tasks and services include:

  • Consulting with patient engagement specialists, partners and services
  • Working with patient support and advocacy groups to identify patient needs and desires
  • Identification and active participation in patient communities
  • Defining patient engagement evaluation criteria and metrics to engage with minimum burden
  • Options and timing for return of data to the patient (patient and study)

Communication Engagement:

Taking knowledge from, and building on, the essential engagement services, communication engagement should define and include the most efficient and effective ways to communicate with our patients.  Patient communication encompasses the bi-lateral sharing of information about the study itself, the planned interventions, general disease information, patient support resources, questionnaires, surveys and scales and logistics such as medication tracking.  Methods of communication engagement may include:

Central patient portal / environment / website / app(s)

Videos, digital leaflets and newsletters

Visit schedule / calendar downloads and syncing, visit alerts

Patient communities and outreach

Chat rooms, wikis, blogs, advocacy group links/FAQs

eCOA communication services e.g. compliance metrics/feedback, satisfaction surveys, reminders

Conversational AI and (digital) patient concierge services

Motivation Engagement

Motivating our patients to maintain engagement momentum is key to both patient adherence and successful study completion.  Motivation engagement should include several methods including:

Provision of study devices such as wearables, monitors, digital health sensors etc

Mobile apps with potential for gamification / achievement tracking and sharing

Thanks and acknowledgments

Expense reimbursements where appropriate

Relevant and timely return of patient data to the patient via summaries, reports, achievements etc

Activities 

Included activities in the RFP:

The following activities are included in the RFP:

  • Patient / study data return – method of providing individual patient data back to the patient in a way that engages, empowers, provides insight into patient’s personal health / disease state or progression etc.
    • Visuals, text, awards, recognitions
  • Engagement consulting services – digital engagement program for duration of study
  • Social Media capabilites – program for duration of study
  • Conversational AI

Excluded activities from the RFP:

The activities below are already covered by internal partner and excluded from the RFP:

  • Central patient portals / apps
  • APIs, integrations, interoperabiltiies
  • Calandar, schedule, visit management
  • ECOA
  • Patient concierge
  • Device independence
  • Messaging, rewards, thanks, achievements etc
  • Compliance
  • Clinical monitoring

Functional Requirements

Essential Engagement Services:

  • Social media expertise with relevant advocacy groups, patient communities
  • Ability to host, aggregate, consolidate, update and display patient’s personal health data inaccordance with security and privacy requirements (safety/privacy, GDPR-compliant)
  • Ability to request expense reimbursements where appropriate
  • Relevant and timely return of patient data to the patient via summaries, reports, achievements etc
  • Ability to host, aggregate, consolidate, update and display patient’s personal health data inaccordance with security and privacy requirements (safety/privacy, GDPR-compliant)

Additional Non-Core Services:

  • Conversational AI and/or chat-bot services through central portal and/or patient’s own smart devices (Alexa, Bixby)

Technical requirements

  1. Readily available APIs to enable integration / interoperability / single sign-on features
  2. Device independence:
  • Can be accessed / run by both android and iOS fixed and mobile devices and operating systems
  • Support for all common browsers and browser release versions
  • Available and can be synced with desktop URL site
  • Can be used with incumbent smart devices such as Alexa, Bixby etc
  1. Any companion apps, wearables and medical devices – if applicable – should allow:
  • Sufficient battery life with ease of recharge
  • Lightweight, unobtrusive/discreet design
  • Relevant safety certifications, documentation
  • FDA device classification and/or CE approval (and covering any companion mobile apps)
  1. Compliance with:
  • GxP regulatory requirements
  • GDPR / Privacy requirements
  • 21CFR11 / EU CTR / ICH GCP

RFP –  Knockout Criteria:

For the activities included in the RFP we have identified a number of knockout criteria that will exclude the technology vendor in the case that one or more of them are not met.

Patient / study data return

The technology will be rejected if:

  1. Not compatible with any/all mobile devices
  2. Not compatible with any/all browsers (latest version + previous still-supported common versions)
  3. Language limitations

Engagement consulting services

The technology will be rejected if:

  1. Inexperience in Diabetes TA

Social Media capabilites

The technology will be rejected if:

  1. Inexperience in Diabetes TA

Conversational AI

The technology will be rejected if:

  1. Not compatible with any/all devices
  2. Not compatible with any/all browsers (latest version + previous still-supported common versions)
  3. Language limitations
  4. POC / infant product

Basic Building Block Profile

Building Block: Intervention & Follow-Up

Vision

We envision a digital platform, containing multiple connected systems where all essential study records (e.g. eCRFs, uploaded eSource documents, electronic health records, scheduling), are contained under a single login. This digital platform connects the decentralised site resources (PI, Study Coordinator/Research Nurse, home health staff, concierge services) with each other.  It facilitates a seamless workflow between investigational site personnel and promotes a well-integrated, positive patient-investigator experience. This is a platform for tracking biological samples, devices and IMP shipment, videocall connectivity with study participants, and allows for home and remote visit note taking (details to be captured for record keeping and for eCRF completion).

Activities involved in the BBB

Functional requirements

  • Help desk service, to provide first point of contact for decentralised site staff technical support
  • Participant concierge service, g. equivalent of a physical site front desk staff, first point of contact for participants, also making outbound calls to schedule and remind about visits, shipments, compliance management, etc.
  • Logistics, e.g. IMP shipments direct-to-patient or local pick-up depot, possibility for affordable disposable / re-usable cold-chain tracking solution to be included. Biological sampling shipment from patient’s home to local or central labs
  • Smart medication solutions for an injectable IMP with near real-time connectivity:
    • Smart dosing solution (cap for insulin pen)
    • Adherence & inventory data capture app
  • Telemedicine tool, to include the ability to connect external devices (i.e. cameras, vital sign monitoring systems, wearables) 

Technical requirements

  • Recording and transciption capability (optional) for video and phone calls (i.e. telemedicine visits, remote coordinators phone calls, etc.)
  • Logistics, telemedicine, smart medication and Point of Care devices are required to integrate into eClinicalHealth Clinpal platform

Excluded activities from the RFP

  • Home Health Visits
  • Self-intervention & Self Monitoring
  • Clinic Visits

Knock-Out Criteria

Submissions will be rejected if:

  • Not able to demonstrate prior cases of at least two different clinical trials wherein IMP (from study drug assignment to drug destruction) and met EMA inspection standards.
  • Demonstration of IMP management systems do not conform to reviewers’ expectations.
  • Non-compliant with GDPR
  • Non-compliant with 21 CFR part 11

Submitting your proposal

We request you to create a proposal for the technologies that you are able to deliver. Please be very clear about the functionalities of your proposal: what part of the scope can be covered?

Also we would like to receive a total price, that shows at least the following components:

  • Give a clear definition of the scope and detailed assumptions
  • Present an overview with costs per line item (no lump sum)
  • Per task indicate the estimated hours and role per task (including hourly rates)
  • If applicable, detailed information about license costs per month/year/user etc
  • Transparency when you outsource parts to third parties
  • Overview of other costs and pass though costs.

You will be able to upload your proposal on the T@H website by clicking the ‘Submit a proposal’ button below.

After you have submitted a proposal for one or more of the requested technologies from the RfP, your proposal will be quickly checked on the knock-out criteria per relevant BBB. After a positive conclusion, you will receive a survey including instructions from Trials@Home. We kindly request you to fill in this survey, including remarks and documentation / proof to strengthen your answers, and return this form ultimately within 2 weeks.

Important Dates

  1. Webinar with further explanation of the project & RfP: 6 Jan 2021, 3 PM CET 
  2. Deadline for submitting a proposal: 15 Jan 2021
  3. Deadline for returning self-assessment form: 29 Jan 2021
  4. Pitch + interviews: 16 Feb – 1 March 2021

Assessment process & criteria

After submitting a proposal and returning a completed survey, per BBB these documents per vendor will be assessed. First a check will be done on the knock-out criteria that apply. Then, if passed, the formal assessment will start. Per BBB, an assessment committee is composed, that will score all proposals including a self-assement survey, based on pre-defined quality criteria and vendor characteristics. You will find these quality criteria per BBB in the document ‘Quality criteria per BBB’.

The self-assessment will result in a ranking per BBB. Numbers 1, 2 and 3 of this ranking per BBB will be invited for a pitch & interview. Their offer will be discussed, and the assessment team is allowed to adjust their scores per vendor after this pitch and interview.

The vendor that ranks number 1 after the pitch and interview, and is assessed as fit for purpose, will be nominated as candidate technology for the pan-European pilot study.

Please note that, due to different unforeseeable circumstances, T@H always has the possibility not to award a contract.

FYI, upon award of services, the attached contract template will be completed and executed. The standard terms and conditions are non-negotiable.

Questions

All interested vendors may ask questions during this RfP. You can do so by sending your question per e-mail to: trialsathome@umcutrecht.nl.

Questions will be collected and answers will be – open to everybody – uploaded on the Trials@Home website.

Submit your proposal
Submit your proposal

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Webinar Slides

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FAQ

Click on the image to download the FAQ document. This document will be updated regularly with all questions received prior to the submission deadline. Current version dates 13 Jan 2021

CDA Template

Please click here to download a signed copy of our CDA to add to your submission if you prefer doing so