Selection of a CRO – Request for Information

SELECTION SPECIFICATION

Selection identifier: RFI CRO

Contracting Authority: Fondazione Penta ONLUS

Deadline to submit the requested information: 31 March 2022 12 AM CET

Language in which proposal should be submitted: English

Email address for further information: chiara.messina@pentafoundation.org

 

ABOUT THE CLIENT

Penta is an international scientific research network into child health. We are an independent global collaboration devoted to determining and implementing the best ways to prevent, diagnose and treat diseases in children.

Fondazione Penta ONLUS is the coordinating hub of the Penta ID Network, which is made of more than 300 researchers and 110 sites in 31 countries. With the skills, experience and expertise of all our Network members, the Penta Foundation develops and deliver world class research and training to drive understanding and good practice around the management of infections in children.

The Penta Foundation is involved in research projects that operate along the scientific priorities: HIV & viral infection, severe sepsis and antimicrobial resistance, infection in pregnancy and neglected or emerging childhood infections. Our research embraces basic, pharmacological, clinical, social and population sciences.

 

SCOPE OF THIS INFORMATION

Fondazione Penta ONLUS is looking for a Clinical Research Organization to support the set up and execution of clinical trials that will be starting in 2022.

 

PHASE I. Request for Information

During the first phase, Penta will be evaluating if the Clinical Research Organization (CRO) has the necessary technical requirements to be considered as a potential provider for services to support Penta clinical activities.

CROs that fulfill Penta requirements and standards will then be moved to the selection process (Phase II).

 

Characteristics of the provider

  1. The provider shall be a CRO operating in the field of clinical trials, with proven expertise in the conduct of paediatric clinical trials worldwide.
  2. An accreditation or an on-going accreditation process by a certified accreditation body will be an asset.
  3. Previous experience. Previous work with international organizations and/or major pharmaceutical industry in the field of paediatric clinical trials. Proven experience in clinical trial management, including regulatory support, site management, safety and clinical monitoring, study report writing, etc. of clinical trials, including vaccine trials.
  4. Logistical capacity. The CRO shall have the ability to operate worldwide and to conduct all activities listed in section
  5. Contractor staff dedicated to the project must have appropriate qualifications, training, and experience.
  6. Key Performance Indicators. Quality of execution, speed and reliability shall be reviewed.

 

Request for Information (RFI) Structure

The contents of the RFI should be concisely presented and structured in the following order to include, but not necessarily be limited to, the information listed in sections below. Any information which the CRO considers confidential, if any, should be clearly marked confidential.

  1. Company Information

1.1 Corporate information:

  • 1.1.1 Company mission statement
  • 1.1.2 Service commitment to customers and measurements used
  • 1.1.3 Organization structure
  • 1.1.4 Geographical presence
  • 1.1.5 Relevant experience (include description of those parts of your organization that would be involved in the performance of the work).

1.2 Staffing information:

  • 1.2.1 Number and Geographical distribution of staff by role
  • 1.2.2 Number of consultants employed on similar projects in each of the past three years
  • 1.2.3 Staff turnover rate by role for the past three years.

1.3 Audited financial statements for the past three (3) years.

1.4 Legal information:

  • 1.4.1 History of Bankruptcy.
  • 1.4.2 Pending major lawsuits and litigations in excess of Eur 100,000 at risk (indicate particularly those by licensees or patent infringement)
  • 1.4.3 Pending Criminal/Civil lawsuits.

1.5 Relevant Contractual relationships:

  • 1.5.1 Relevant Contractual projects (with other paediatric networks).

1.6 Proposed sub-contractor arrangements including sub-contractor information (as above for each sub-contractor).

 

  1. Experiences and Reference Contact Information

Where possible, list and provide five (5) detailed examples of relevant experience gained within the past five years of the issuance of this RFI that demonstrate the contractor’s ability to satisfactorily perform the work in accordance with the requirements of this RFI.

2.1 Project Name:

  • 2.1.1 Project Description.
  • 2.1.2 Status (under development/implemented)
  • 2.13 Country of Implementation
  • 2.1.4 Reason for Relevance (provide reason why the project can be seen as relevant to Penta)
  • 2.1.5 Roles and responsibilities (list and clearly identify the roles and responsibilities for each participating organization, focusing on Contractor Role and Responsibility).

 

  1. Key Performance Indicators (KPIs)

Last two years KPIs for the following activities should be provided as a minimum.

  • 3.1 Number of active studies/ total FTEs
  • 3.2 Clinical Research Associate turnover
  • 3.3 Time to deliver first monitoring report
  • 3.4 Time between LPLV and database lock
  • 3.5 Time for production of first Clinical Study Report.
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