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Information about CRO RFP
Health & Medicine

Published on February 20, 2014

Author: mwright1


May 191 RE: Dear Request for Proposal ("RFP"} -Clinical Trial Study Management for "Phase II Study of. .for the Treatment of Patients with Severe Acute Pancreatitis" Ms. .Corporation would like to invite to submit a proposal and cost estimate for conduct of a Phase 2 clinical study in severe acute pancreatitis. As you know, .-a biotechnology company that is focusing on discovering and developing new pharmaceuticals for inflammatory conditions and related diseases. This study will evaluate the effects of recombinant human .in patients with severe acute pancreatitis. .r , IS a potent pro-inflammatory phospholipid with diverse biologic effects. :orporation is developing. as an agent for treatment of patients with severe acute pancreatitis. We are seeking a full-service contract research organization (CRO) that has the capability to manage and perform site coordination. site initiation, on-site monitoring, randomization, site contracting and payment management, biometrics, data management and reporting services and management of central and core laboratory services. This RFP consists of an introduction, the- proposal instructions, a protocol synopsis, work breakdown, timeline and contractual terms and conditions. All instructions and requirements should be followed to ensure that a proper evaluation can be performed. The information furnished in your proposal must address the specific items listed but may also include any additional data you consider relevant to the RFP and meeting the needs of This RFP contains infonT1ation which is confidential to. and must be handled in accordance with the terms and conditions in the Confidentiality Agreement which has been signed by and - Page' of 34

Nothing in this RFP shall be construed as an obligation by you or into a con1ract or other business relationship 1ogether in connection subject matter of this RFP . iO enter with the The anticipated schedule for this proposal and selection process is as follows: . . . RFP Response due back to RFP Award Finalized Contract and Statement of Work June 3, June 19, July 31 , Your completed proposal should be delivered in person or by express delivery to the undersigned no later that 5:00 PM, June 3, Proposals received after this time may not be considered. Please acknowledge your receipt of this RFP. If you. do not plan to respond, I would appreciate your notifying me as well. Between receipt of this document and Thursday, May 20th, you may contact me at. -for questions. Questions directed to .~ at Again, thank receiving you for your interest in coming after and this Study. or email May 20tn should be We look forward your response. Sincerely, Clinical Research Associate Enclosu res cc Page 2 of 34 to

Request For Proposal (RFP) Instructions In support of this clinical study, ..requires the services as outlined in Attachment 4, Task and Responsibility In preparing your proposal, please adhere to the instructions and conditions contained in this RFP. The following instructions and conditions are intended to assist you in the preparation and submittal of a response to the RFP . Please submit the proposal as outlined below: 1. Proiect Manaaement Accroach: Please provide an overview of your project management approach in general and how it would be applied to this study. The names of the project manager and team members who would be committed to theproject should be included and their CV's submitted with the RFP . 2 Past Pe[{ormance and Comcanv Information: to complete Attachment I, Vendor Information 3 ~gnt work. Please provide the information and aualifications. required of Wor~; Attachment IV, Task and Responsibility List, details the scope may elect to contract for these items individually, in any combination of or collectIvely. Alternative or additional services and products which meet the needs of the project may also be proposed. Such products and services should be identified clearly as additional or alternative and should include all relevant information for each product or seNice proposed, including but not limited to (i) a detailed description of the product or service. (ii) effect on the schedule, (iii) pricing information, and (iv) specific RFP item affected or replaced. Note: Refer to Attachment VI, Data Management Organizations when pricing the data management portion Requirements for Contract (items 16-20) of this RFP . 4. Pricina: Submit the budget in a format that details the price per task as outlined in the Task and Responsibility List. Where possible, a per unit cost and extended line item cost should be provided (an example would be Project Management at $1,000/month extended to $12,000 for a 12 month project or data management services priced based on a per CRF unit cost. Estimated pass-through expenses are also required. A second price format should be submitted using the Resource Allocation Worksheet, Attachment 5. The cost per personnel assigned to each task should be given by FTE, rate/hour and the total (an example is a CRA @ 100% FTE for 12 months @ $30.00/hr totals $62,400). Note: 5 Contracts: Total amounts It is for each format should be the same. J intent that any proposal which is awarded as a result of this RFP process will be governed by the Master Services Agreement provided with this RFP as Attachment 7 or such other agreement which has been negotiated previously with your company. In the event exceptions are taken to these terms and conditions or any Page 3 of 34

  • other contractural requirements contained in this RFP, such exceptions must be clearly stated in your proposal. All exceptions must be identified by section, paragraph, and line(s) of the agreement as appropriate, with clear justification for the exception. Altematives and/or resolutions for each exception taken should be proposed. Any exceptions will be a consideration in evaluating the proposal and are therefore requested to be kept to a minimum. 6. ~ Site Visit: During the proposal evaluation period, an. .j team may visit your organization at your facility(ies) or any proposed sub-contractors or may request that your team or sub-contractor provide a briefing at j in order to better understand your proposal. ~ncillarv Service: This protocol assumes the use of a central laboratory. Please include any information you wish to be considered regarding central laboratory service providers with which you have an established relationship and the nature of the relationship. Administrative: If your proposal clearly indicated Please submit five (5) unbound copies of your proposal. is to be submitted to on an 'lall or nothing" in your response to the RFP . Upon completion of the evaluation process, your organization basis, will be notified this in writing Attachments I -Vendor Information and Qualifications 11- Study Synopsis 111- Study Overview IV -Task and Responsibility List V -Resource Allocation Worksheets VI -Biometrics Division-Data Management VII -Master Services Agreement Expectations for Contract should Organizations Page 4 of 34 be
  • ( AttJchment VENDOR 1. INFORMA Backaround Company Parent I: Request TION AND QUAURCA for Proposal TIONS Jnfonnation Name: ~ Company: Other Divisions : Street Address: City, State. zjp: Telephone: Fax: Publicly Ownership: held Privately held Year Founded Contact(s): 2. Financiallnformation Attach adodional sheets as necessary (..NOTEAJlfinancial informa1ion will be held in strict confidence. If desired, financial infonl'ation ur questions may be directed separately to Robin Moore, Business Manager -Clinical Affairs.) Banking References: .Institution Name and Contact Information Financial Statements .Balance Sheet .Income Statement .Statement of Cash Flows Dun & Bradstreet Report, if available
  • Attachment III: Request for Proposal STUDYOVERVIEW: Institutional Review Board Sites will use ttleir local IRB Studv Duration 10 monjh Site Qualification on Site Visits & Time Visits & Time on of Frequency 30 of 30 visits; an average of 30 Approximately Visits & 8 visits Time on Site & Time on Site 1 visit every 8 weeks or per every 1-2 enrolled per site for a total of 16 hours Visits to qualify per visit per visit oatients Close-out of 34 visits of 5 hours per site for a total A Interim Monitoring a total 300 (150 per ~m) Sites Site MonItoring 1 visit 6 hours Number of Patients I Number per site; an average 28 davslpt A , .5 day meeting with a session on Friday evening concluding on Saturday, the meeting will be helQjn SeDtember '998 Investigator Study Start-up Meeting Site Initiation Site , visit sites; enrollment; or 2 days per site for a total 12 hours or1.5 davs of 240 visits; an average per visit of 30 visits; an average of peryisit Pharmacy Monitoring Frequency Initial visit after 1-2 patients enrolled then approximately every 8 weeks or per every 4-6 Pharmacy MonitorIng Time on Site Visits 4 visits Qatients enroll~d & Number of SAEs Anticipated Case Recor1 Forms per site for a total of 4 hours I App of 120 visits; an average per visit roximately ! Ao~oximatelv 200 50- ~aQes per patienL Data Manaqement Acproximate~ 15,000 CRF DaQe~ total Interim Performed after completion of 150 pts. Efficacv Statistical Clinical/Statistical Analvsis CRO to perform a final statistical analysis of the data t~nclude 30 tables. 23 Jistinas, and §1!Qu[es Analysis Report This timeline is based on approval CAO to write inte~ated of the protocol recort by the FDA and IRB and patient accrual. Page 10 of 34
  • Attachment TASK AND RESPONSIBILITY IV: Request for Proposal LIST: IMPORTANT: As described in the RFP Instructions, please provide pricing for each line item outlined in the Task and Responsibility List below. CRO I!TEM 1 -Requ!ato!V Provi~~)nv~s!Lqator x x x x x x Brochure I Prep~re updates annuallNQ -commu~~Jelated FDA to st~dy- -Compi'e/su~~i!-!)oc-u!!!ents I SIte to FDA Reqistration IIND Safety ReDorts I 2 -Protocol ~ Study Pr~p-ara~'on x x x design- I Write crotocol Draft Informed consent I 3 -~as~Report I Desig~ Form case report PreDaration for!::!:ts Jo ICOS Print ca~e report forms ~ICOS 4 -Pre-stud standards Preparation Identification x x standards . of ~otential jnv~tigators -- p x x x x x x ~ x- p p x x rSite eva~atio~ visits/reports I Site I AB selection submissions Collecti~n of sJte requlatory documents I Sub~ si~ reqistratiofl I Prepar~~-iudy I 6 -Study l Develop ~ Cond~ct I Pro~de I f -Site Mee-ting - inve~~g~1Q! ~onduct to sponsor manual 5 -Invesligator LPlan do~ments meeting inv~stigator meetinQ Initiation ~1te requlatorv InitiatiOn J!:!ltlation visit ~inders ~ visi~epor1 each site for each site Monitorinq Provide wrItten reoort Maintain weekly telephone contact with study sites Provide ~)ephone repoi!~ ~ai~ x x x ~udy re9ul~torY~nder x x x x x x p = Primary Paae 11 of 34
  • 3 Services -~-Attach Offered-- additional sheets as necessary Service I ca~~~Fom1 I Yes Production centrallRB F' ~urchasinq Packaging Labelin~ :)ution rco~~'lstems ~~lelopment , Consumer Product -Central- Contrad. Data ---~~ LaboratO sy$lem) -- ManaQement , GCP I ~9SCIibe Testinq Monitorina- 6Utcomes~Research 11~nTIed cons~ draffing i l~pa:Bent P~~se I fac:il!~(ies} , Investigator Budge1 I -Jnv~g~~or G~tAdm~~tio~ Negotiation I InvestiQator MeetiI'1g pl~nriinq --~ MedicaVTechnic:a1 i Dossiers Writing - Final Reports Manuscripts , Protocol rprotocol Developm-ent F ea-sibili:::y-~alysis -o]:jcompliiince ~drtJnq Rc:ind0m"iZ3tion'S=hedule IVRS ~ Genei:ation ReQula~-I)'-Subr;1is~s INDs Investjgator ~ocumentation N DAs/ MAAsIP LA AE and sAE flintrace I statistical ~ : Remote Other for S~ Reporting A1'1aly~ Data (specify) Entry I (de:scribe system) No Through 3ro, party supplier Comments

    Busines 4. ercent of business ot ca p~ PreClfn'cal Ph3se Ptl3S8 IV Consumer M~icines Rx10 III Phase , OTC II Laboratory Testing Rf.'9ul2IDry Sbti.1iC31 Analysis Switt11 01.. Identify three (3) closest competitors in your primary business focus: 1 2: 3. Identify three (3) closest competitors in your secondary business focus: 1 2. 3. Identify your core competencies: 2. 3. 4 Describe the characteristics (be as specific as possible): and/or services that differentiate you from your competitors 1. 2. 3, 4. 5 ClilJical Please 1 Trial Manaaement provide the Experience following: A description of study(ies) your company has conducted in a setting and/or specialty similar to the trial being proposed {aiticaf care, Gt-paneFeatitis) since 1994. Include the specific indication, phase, number of patients, and number of sites (domestic vs. foreign). 2. Describe the role your company project managem~nt, 3 6. Describe proposed Business List Board monitoring your plan for in this RFP . Oroanizaticnal of Directors had in conduct only , data management identifying Structure of those and appropriate Related study(ies), only. sites/investigators Information eg., complete for the study

    Attachment II: Request for Proposal STUDY SYNOPSIS: Study Title: StudyObjectives: Phase II study of severe acute pancreatitis I for the treatment of patients with Determine if treatment with. .i decreases the incidence and extent of multiple organ dysfunction syndrome (MODS) in patients with severe acute pancreatitis Compare survival time over 28 days and point mortality at Day 28 between treatment groups Evaluate the effect of utilization (e.g., ICU procedures, medication treatment on medica[ resource and hospital lengths of stay, major utilization, etc.) Characterize safety and phamlacokinetic in critically ill patients Study Design: Randomized, double-blind, parallel treatment groups behavior multicenter, pJacebo-controlled, Approximately 300 patients (150/treatment randomized to one of two treatment groups: Number Patients 150 150 Group ~ Test Agent: naturally contains of ~ group) Placebo: Formulation Efficacy Assessments: Determine will be Grou reatment Placebo 5.Q mqlkq is the recombinant form of human occurring enzyme which degrades --. , ;0. an inactive metabolite. the formulation of . vehicle I ... «, a The placebo for vehicle for incidence and extent of MODS (Grit 1995;23: 1638-52) time over 28 days by capturing Med over the 28 day study period Calculate Care survival of death in patients date and time expiring Assess the economic profile of t when administered as a treatment for severe acute pancreatitis by comparing the relative medical resource consumption between treatment groups Safety Assessments: Safety endpoints will include reporting and tabulation of adverse events and clinical laboratory parameters (i.e., hematology, biochemistry. and urinalysis) and assessment of Page 8 of 34

    I. the potential immunogenicity of. Interim analysis to assess safety and efficacy will be performed on one occasion Key Inclusion Criteria: Onset of abdominal pain treatment with test article ~ 48 Serum amylase limit of normal or lipase Clinical and diagnosis evidence APACHE hours concentration prior to initiation ~ 3 times the of upper of acute pancreatitis II Score ~ 6 Test Agent Administration: 10 minute Frequency of Evaluations: Baseline (.:$. hours prior to first dose of test article), 24 daily on Days 1-7, Day 14, and Day 28 Laboratory To b~ performed by local and central laboratory Tests: Duration of Patient IV infusion daily for five consecutive days 28 days Participation: No./location of Sites: 30 sites located in the United States Start of Patient Enrollment: 3098 Monthly A minimum Enrollment: Enrollment Duration; of 1-2 patients/site/month Approximately 10 months Project Duration: Approximately 17 months Outside Services: Central Laboratory Drug packaging and distribution No. 50 of CRF Pgs./Pt.: page 9 of 34 -..'.'.'...1 "..; 0-'- -'")-.,-::-

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