Docstoc

National Institute for Clinical Excellence (DOC)

Document Sample
National Institute for Clinical Excellence (DOC) Powered By Docstoc
					Document 3


    National Institute for Health and Clinical Excellence

      Requirements specification to source external
                        expertise for
      Scientific Advice Programme, Centre for Health
                   Technology Evaluation

Final version October 2010


1      Introduction
1.1    The National Institute for Health and Clinical Excellence (NICE) is an
       independent organisation responsible for providing national guidance
       on the promotion of good health and the prevention and treatment of ill
       health. Documents describing the methods and process employed by
       NICE are available from the NICE’s website (available at
       www.nice.org.uk).

1.2    The Scientific Advice programme provides advice about NICE’s
       evidence needs during its technology appraisal processes to the
       developers of new products. Mainly these are pharmaceutical products
       but in future this may also include diagnostics and medical devices.
       Developers may use this advice to best structure their clinical trials to
       ensure the necessary evidence is gathered. More information about
       the programme is available on
       www.nice.org.uk/aboutnice/scientificadvice.

       During each project, NICE’s technical team require support from both
       expert clinicians and health economists to provide this service and a
       supplier is sought to source and mange this expertise


1.3    Currently the programme is delivering approximately 25 projects per
       year, however this may increase. For the purposes of this tender, NICE
       will guarantee a minimum activity level of 10 projects per year.

1.4    The contract with the supplier will be for 18 months.


2      Role of the supplier
2.1    The role of the supplier is to source and manage the external expertise
       required by each advice project in NICE’s Scientific Advice programme.
       The supplier is expected to have effective project management skills to
       plan and coordinate the delivery of each task to time and quality,
       ensuring that the agreed specification for each task is followed
       appropriately.


                                                                               1
Document 3



2.2    Specifically, for each advice project the supplier is expected to:
          identify 3 - 5 appropriate experts (e.g. key opinion leader
              clinicians, health economists, statisticians, etc) to participate in
              this project
          ensure the availability of the experts to work on the project
              within the timelines required by the programme
          negotiate and manage all contractual issues with the experts
              (e.g. terms and conditions, payment)
          arrange the travel and accommodation for the experts as
              required
          be responsible for payment of experts’ expenses
          comply with NICE’s confidentiality and conflict of interest
              requirements, ensuring the confidentiality agreement forms are
              signed and returned by experts
          provide a breakdown of costs on a project by project basis.
          participate in a weekly teleconference meeting with NICE staff
              Attend quarterly contract monitoring meetings with staff of the
              Scientific Advice Programme

2.3    Experts will be expected to:
           review the written information supplied by the company about
             their product.
           participate in teleconferences with the NICE technical team to
             discuss the information.
           attend a face-to-face meeting with NICE staff and client
             company representatives in London or Manchester on 8 – 10
             weeks’ notice.
           contribute to the discussion of key issues at the face-to-face
             meeting
           comment on and contribute to the draft NICE advice report to
             the company
           comply with NICE’s confidentiality and conflict of interest
             requirements.

2.4    A clear, consistent and unbiased process must be used to source the
       experts. Experts may be sourced externally or from within the
       supplier’s own organisation. In the latter case the supplier must clearly
       demonstrate that the experts are qualified and that any conflicts of
       interest are managed in accordance with NICE policy (Declaring and
       Dealing with Conflicts of Interest). NICE stipulates that experts cannot
       be serving members of the technology appraisal committee or other
       relevant NICE committees that may issue guidance on a product for
       which advice is being given.

2.5    Milestones for the provision of expertise are as follows:

Item                                                       When
Assess the type of expertise required (e.g. clinical       Within five days of


                                                                                     2
Document 3


knowledge of the therapeutic area, health                  receiving the briefing
economics, modelling or other expertise), level of         book prepared by the
expertise (e.g. consultant, professor, senior              company on its
researcher, etc) and number of days of each type of        product in
expertise required to provide advice on the product,       development
and discuss with NICE to agree the NICE
specification for a) the type, level and days needed
of expertise, b) the complexity of the project, and c) a
draft timetable for the project
Send to NICE the list of experts, their affiliation and    As soon as possible
the justification for their choice, and confirm their      after receiving the
availability for the face-to-face meeting                  confirmed project
                                                           specification from
                                                           NICE and normally
                                                           within ten (10) working
                                                           days of receipt of the
                                                           confirmed project
                                                           specification from
                                                           NICE


3      Skills required
3.1    Some of the attributes NICE requires of the supplier are:
             an understanding of the methods and processes used to
              develop NICE technology appraisal guidance. A copy of NICE’s
              methods is available at
              http://www.nice.org.uk/page.aspx?o=201974
             familiarity with the conduct of clinical and health outcomes
              research in the pharmaceutical industry
             access to a broad network of highly qualified experts and key
              opinion leaders including health economists, clinicians and
              statisticians drawn from academia and the NHS
             ability to identify the specific expertise required and match it to
              the skills of the expert
             experience in working with commercially sensitive and/or
              confidential information
             a proven track record of efficient and effective project
              management
             experience of managing contracts
             experience of providing services to commercial clients.
             a good understanding of, and sensitivity to, the environment
              within which NICE operates
             familiarity with and commitment to work within the legislative
              environment in which NICE works (e.g. Freedom of Information
              and Data Protection Acts)




                                                                                    3
Document 3


4     Monitoring and evaluation
4.1   The performance of the supplier will be monitored against delivery of
      the specifications set out in section 2.


5     Conflicts of interest and confidentiality
5.1   There is a potential for conflicts of interest and issues of confidentiality,
      since the advice is provided on products which are under development.
      It is important for you to indicate where you anticipate areas of conflict
      with your existing work base, or conflicts which external experts might
      have, and how you would handle issues of conflict of interest and
      confidentiality.


6     Timescales
6.1   The contract must be in place by 1st June 2011
6.2   Expressions of interest must be provided to NICE by Monday 1st
      November 2010 (5.00pm – 1700hrs) and the deadline for the receipt of
      tenders is 12:00 midday on Friday 3rd December 2010.
      Please note that expressions of interest or tender responses received
      after the specified times, cannot be accepted by NICE.


7     Your proposals
7.1   Within your proposals please address each of the sections in the
      number order given below

      1.     Please provide a summary plan outlining how you will meet the
             requirements of the role.
      2.     The summary plan should outline how you intend to undertake
             the specific tasks described in section 2, including:
                    what your network of contacts is and how you will ensure
                     you find appropriate experts for every project
                    the processes you will follow to source the specialists
                    the resources necessary (e.g. staff involved, their
                     expertise, estimated time commitment per staff member)
                     to meet the requirements (brief information should be
                     given here and details should be given in costing section
                     below)
                    the project management methodology and the monitoring
                     tools you will use to track delivery to specification
                    the accounting and billing procedures. (Please note that
                     contracts will be based on the attached blank agreement
                     which is included for your legal review)



                                                                                  4
Document 3


                   how you will ensure that both you and the external
                    experts meet NICE’s requirements on confidentiality and
                    conflict of interests.

     3.      The response should also include a description of the relevant
             skills within your organisation, in particular:
                   your organisation’s experience and understanding of
                    NICE’s technology appraisal processes
                   your organisation’s familiarity with the conduct of clinical
                    and health outcomes research within the industry
                   your experience of efficient and effective project
                    management
                   your experience of managing contracts
                   your experience of working with commercially sensitive
                    and/or confidential information
                   your experience of dealing with conflicts of interest
                   your experience of working within the limits of Data
                    Protection and Freedom of Information Acts
                   your experience of working within the UK health care
                    environment

     4.      Costing: Based on the following assumptions:
                there will be a minimum of 10 projects per year with an
                   average of 10 expert days per project = a minimum of
                   100 expert days per year
                three experts are generally required for each project
                   although on occasion it could be more. The experts for a
                   project will have a range of different types of specialty
                   knowledge (e.g. clinical expertise, health economics
                   expertise, etc) and different levels of expertise (e.g.
                   professor, lecturer, etc)
                your management and administrative costs per project
                   should be detailed separately from the experts’ costs.
                the direct costs (fees and expenses) of the experts must
                   be passed on to NICE with no additional uplift by the
                   supplier
                for the avoidance of doubt, the invoice from the supplier
                   to NICE should consist ONLY of the supplier’s
                   management and administrative costs and the experts’
                   direct costs on a pass-through basis

             You are required to:

                   provide your management and administrative costs
                    (exclusive of VAT) that you would charge to undertake
                    the minimum level of activity, i.e. 10 projects per year
                   state what if any discount you would offer in the event of
                    there being 11 – 25 projects and 26 – 50 projects per
                    year


                                                                                   5
Document 3


                    give your costs on a project-by-project basis, not on the
                     basis of total annual activity
                    state any assumptions used when providing the above
                     costs

             Costing information must be presented in two tables with the
             following format. Failure to provide costs in the format specified
             may result in your proposal being rejected.

      Costs for each project:

      Type of staff or          No. days of      Day rate of     Total cost of
      resource                  this resource    this resource   this resource
                                per project                      per project




      Other project costs
      Total costs per project

      Total costs:

      Management and administrative costs per         £ ___________
      project based on minimum 10 projects per
      year (total costs per project from above
      table x 10)
      Discount offered on management and              ___ % discount on price
      administrative costs per project for 11 – 25    of up to 10 projects
      projects p.a.
      Discount offered on management and              ___ % discount on price
      administrative costs per project for 26 – 50    of up to 10 projects
      projects p.a.

             All offers are to be quoted in GBP and be exclusive of Value
             Added Tax.

      5.     The response is to include a summary sheet detailing the
             benefits of your proposal and where your proposal adds value
             for money.

      6.     Your response should be presented in a clear and concise
             format focusing on the requirements.

7.2   Policies and Financial Statements
      Please provide one copy each of your organisation’s Health and
      Safety, Environmental, Equal Opportunities and Diversity in the Work
      Place polices, together with the last three years of audited accounts for
      your organisation and a current balance sheet.



                                                                                  6
Document 3


7.3   All offers must be written in English.

7.4   All offers must be submitted in accordance with the documentation
      provided in the covering email. This must not be amended in any
      way.

7.5   All offers must be submitted electronically by email to:
      Contract.bids@nice.org.uk and be received by no later than 12.00
      midday on Friday 3rd December 2010.

      The Form of Offer must be submitted in hard copy to:
      Name redacted under section 40 of the Freedom of Information Act
      NICE, City Tower, Piccadilly Plaza, Manchester, M1 4BD

      The envelope must not identify the name of your company.

7.6   Failure to comply with these instructions may result in your offer
      being rejected.


8     Selection criteria

8.1   The following selection criteria will be used to assess the bids received.

       Selection Criterion                                     Weighting
       Financial stability                                     100
       Ability to access leading expertise across a broad      30
       area of clinical therapeutic areas, clinical research
       and health economics.
       Cost and value for money                                20
       Experience of working with commercially                 10
       sensitive/ confidential information and/or for
       commercial clients, and of managing conflicts of
       interest.
       Processes used to ensure effective project and          15
       contract management, and the proposed
       procedures to ensure the appropriate and
       unbiased selection of experts.
       Evidence of understanding of NICE Technology            20
       Appraisals and the context in which NICE
       operates.
       Format of proposal: clear, concise and as per the       5
       requirements




                                                                              7
Document 3




9.     Transparency
       In light of the Coalition governments need for greater transparency,
       Suppliers and those organisations looking to bid for public sector
       contracts should be aware that if they are awarded a contract for this
       work, the resulting contract between the supplier and NICE will be
       published in its entirety. In some circumstances, limited redactions will
       be made to some contracts before they are published in order to
       comply with existing law and for the protection of national security.
       Suppliers are asked to make any sections of their tender that they
       regard as Commercial in Confidence or subject to the non disclosure
       clauses of the Freedom of Information Act or Data Protection Act clear
       within the submission documents. Please note that the total value
       (bottom line) of the agreement is required to be published under
       current EU regulations and the UK governments Transparency
       Agenda. Please do not hesitate to contact us via the process outlined
       in 10.1 below if you require clarity upon this point.


10. Communication with bidders

10.1   Before the offers are submitted, those wishing to tender may have
       specific questions and queries regarding the process, the policy or the
       arrangements with NICE. Under our procurement arrangements NICE
       has to ensure that all applicants receive equal treatment and we will
       share all information requests and responses with all applicants.
       Consequently all questions and queries regarding this invitation to offer
       must be submitted by email to name redacted under section 40 of the
       Freedom of Information Act no later than 5.00pm (17:00hrs) on
       Tuesday 16th November 2010. The questions and answers will then
       be collated and distributed by email to all potential bidders by 5.00pm
       (17:00hrs) on Friday 19th November 2010.

10.2   Please note that that there will be no telephone or informal or other
       kind of discussion between potential bidders and officers or directors of
       NICE after this initial document is dispatched.

10.3   We are planning to communicate the outcome of this stage of the
       process by Thursday 16th December 2010 and will be seeking to hold
       meetings to further evaluate the tenders on Tuesday 18th January
       2011, if necessary. These dates are subject to change.

       All organisations are requested to keep Tuesday 18th January
       2011 free in their calendars.




                                                                               8

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:4
posted:1/11/2012
language:English
pages:8