SOLICITATION NOTICE
70 -- Cytel Software Suite Renewal
- Notice Date
- 8/12/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 511210
— Software Publishers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- fDA-SOL-16-1163455
- Archive Date
- 9/6/2016
- Point of Contact
- Karen L Conroy, Phone: 781-587-7452
- E-Mail Address
-
karen.conroy@fda.hhs.gov
(karen.conroy@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Notice Type: Combine Synopsis/Solicitation Original Posted Date August 12, 2016 Response Date: 8/22/2016 Original Set Aside: Total Small business Classification Code NAICS 511210 Synopsis: This is a combined synopsis/ solicitation for renewal of software in accordance with FAR Regulation (FAR) 12.102(g) and in the format of Subpart 12.6 and 13.5 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotations are being requested and a written solicitation will not be issued. The solicitation number is FDA- SOL -16-1163455 and is issued as a Request for Proposals (RFP). This solicitation document incorporated all mandatory commercial item provision and clauses that are in effect through the Federal Acquisition Circular 2005- 89 dated 7/14/2016. The North American Industrial Classification System is 511210 and the small size standard is 35M 500L This is a firm fixed price contract and is being issued as a "Brand Name or Equal to". If equal items are proposed, the quoter shall provide product specifications for those items proposed. All products proposed (whether brand name listed or equal to items proposed) must satisfy the functional requirements/salient characteristics set forth in this document. Title: Cytel Software Suite Renewal Period of performance: is from effective date of award through 12 months plus one option year. A. BACKGROUND Statisticians and other FDA personnel have a need for specialized software to evaluate, simulate, and analyze clinical trial designs, perform a wide variety of exact statistical analyses and calculations in support of regulatory science for both pre and post market reviews, perform power and sample size calculations for clinical trials, registries, and studies, as well as reliably evaluating designs for the emerging field of adaptive design trials. These specific and specialized capabilities cannot be found in general purpose software products such as SAS, R, Splus or SPSS. Cytel software has been used at the agency for the past 25 years, and is a defacto industry standard for exact statistical analyses, and clinical trial design and analyses, particularly in the emerging field of adaptive designs and group sequential designs. Failure to provide requested software or equivalent may result in the loss of ability to reproduce, verify, and validate sponsor results as well as conducting independent agency evaluations. This loss of capability may result in a failure of reviewers to meet agency deadlines for product reviews. B. OBJECTIVE OF THE PURCHASE The objective of this acquisition is to obtain continuing and expanded access to specialized statistical analysis software for clinical trial design and evaluation, exact statistical analyses in both stand alone and SAS programming environments, power and sample size determination, and adaptive designs for phase I/II clinical trials and adaptive designs for phase II/III clinical trials. Additionally, this acquisition will provide for software maintenance, including upgrades and software patches, as well as technical support for the purchased software product. C. REQUIREMENTS/DELIVERABLES The following Cytel products, or equivalent, are required: 1. EAST 6.4, along EAST Adapt, EAST Survival, EAST Xact and SURVADAPT modules. 2. EAST Endpoints, EAST Predict and EAST Escalate modules. 3. StatXact PROCs 4. StatXact 11 5. LogXact 11 6. Compass 2.0 D.Responcibilities The vendor shall also provide licenses, support and software maintenance, including updates, for the software product. The vendor shall provide maintenance and support existing FDA perpetual licenses of StatXact and LogXact. The software must be capable of running on 64-bit Windows 7 systems. 1. To be considered equivalent to the supplied software product must perform the following: Fixed Sample Size and Group Sequential Designs • Normal Designs o Superiority (one and two sample designs) o Non-inferiority o Equivalence • Binomial Designs (including exact binomial tests) o Superiority (One, two and many samples) o Non-inferiority (two sample) o Equivalence (two sample) • Survival o Superiority o Non-inferiority • Information Based Designs • Adaptive Designs and Simulations o Cui, Hung and Wang methods (Hung and Wang are in the Office of Biostatistics) o Mueller and Schafer binomial methods o Proshan and Hunsberger multi-stage designs o Reanalysis with modified error spending function • Enhanced Survival Designs and Simulations o Superiority o Non-inferiority o allow for random drop outs and accrual rate specification functions o Proportional and non-proportional hazard alternatives o Non-uniform accrual o Study duration estimation o Accommodate differential drop out and varying hazard functions o Allow sample size re-estimation based on unblended interm analysis • Graphics and Charts o Boundaries o Error Spending functions o Power versus sample size • Sample Size Re-estimation o Normal o Binomial o Survival • Interim Monitoring o Nominal Critical Point o Error Spending o Conditional Power o Post-Hoc Power • Traditional rule-based algorithms (3+3) • Continuous Reassessment Methods (mCRM; Goodman et al. 1995) • Modified Toxicity Probability Model (mTPI; Ji et al. 2010) • Bayesian Logistic Regression Model (BLRM; Neuenschwander et al. 2008) • Predicted Interval Plots • Flexible Interim Computation: Accommodate unexpected changes in number of looks and their timing • Simulations of trial endpoints for feasibility studies during design stage • Accurate calculations of power and Type 1 error for ongoing trials • Updating methods for information about trial deadlines and milestones • Predictions of enrollment milestones • Predictions of patient recruitment and country performance • Multiple primary endpoints • Multiple primary and secondary endpoints • Serial gatekeeping • Parallel gatekeeping 2. Power and Sample Size. A Power and sample size calculation software package/component which includes the following analyses and capabilities: Continuous: • Single Mean o Student t o Normal • Difference of Paired Means o Superiority: Student t o Superiority: Normal o NonInferiority: Student t o NonInferiority: Normal o Equivalency: Bivariate Student t • Ratio of Paired Means o Superiority: Student t o Superiority: Normal o NonInferiority: Student t o NonInferiority: Normal o Equivalency: Bivariate Student t • Wilcoxon Signed Rank Test Two Means: • Difference of Independent Means o Superiority: Student t o Superiority: Satterthwaite o Superiority: Normal o NonInferiority: Student t o NonInferiority: Normal o Equivalency: Bivariate Student t • Ratio of Independent Means o Superiority: Student t o Superiority: Normal o NonInferiority: Student t o NonInferiority: Normal o Equivalency: Bivariate Student t • Difference of Independent Means • (2x2 Crossover design) • Superiority: Student t • NonInferiority: Student t • Equivalency: Student t • Ratio of Independent Means (2x2 Crossover design) o Superiority: Student t o NonInferiority: Student t o Equivalency: Student t • Wilcoxon Mann Whitney Rank-Sum Test • Wilcoxon Mann Whitney Rank-Sum Test (2x2 Crossover Design) Many Means • One Way ANOVA o Equality of Many Means o Single Contrast • One Way Repeated Measures ANOVA with Constant Correlation o Equality of Many Means o Single Contrast • Two Way ANOVA: o Equality of Many Means Regression • Linear Regression: Single Slope Coefficient • Linear Regression: Equality of Two Slope Coefficients • Repeated Measures Regression: Equality of Two Slope Coefficients • Multiple Linear Regression • Repeated Regression • Linear Mixed Effects Model: Difference of Means (Crossover Data) • Linear Mixed Effects Model: Ratio of Means (Crossover Data) Discrete • One Proportion • Single Proportion o Exact Test o Normal Approximation • McNemar's Test for Matched Pairs • Two Proportions • Difference of Independent Proportions o Superiority o NonInferiority o Equivalency • Ratio of Independent Proportions o Superiority • One Way ANOVA o NonInferiority Wald Test o NonInferiority Score Test • Odds Ratio of Independent Proportions o Superiority o NonInferiority • Cochran Mantel Haenszel Test of a Common Odds Ratio in a Stratified 2x2 Table • Fisher's Exact Test • Many Proportions o Trend in R Ordered Proportions o Rx2 Chi-Square Test of Independence for Many Proportions o 1xC Chi-Square Test of Goodness of Fit for Many Proportions o 2xC Chi-Square Test of Independence for Many Proportions o RxC Chi-Square Test of Independence for Many Proportions o Wilcoxon Mann Whitney Rank-Sum Test for Ordered Categorical Data • Regression o Logistic Regression : Single Slope Coefficient for a Normal Covariate o Logistic Regression : Single Slope Coefficient for a Normal Covariate Adjusted for Others o Logistic Regression o Probit Regression o CLogLog Regression Agreement • Cohen's Kappa Test of Two Proportions • Cohen's Kappa Test of Many Proportions Time-To-Events • Two Survival Curves • Logrank Test of Equality of Survival Curves o Superiority o NonInferiority Multiple pairwise comparisons with a control: • Continuous endpoint: Difference of means • Binary endpoint: Difference of proportions • Parametric multiple comparison procedures: o Dunnett's single step o Dunnett's step down • P-value based multiple comparison procedures o Bonferroni o Sidak o Weighted Bonferroni o Holm's step down o Hochberg's step up o Hommel's step up o Fixed sequence o Fallback • Generate means through a DR curve • Global, disjunctive, conjunctive, and individual power • Family Wise Error Rate (FWER) • Comparative plots of power, FWER, box plots, estimated means 3. Exact Statistical Methods. A statistical software package developed for use with exact statistical methods rather than asymptotic approximations is required. The functionality of the software should be available both as a standalone statistical package and in a SAS callable form. The following is list of methods and analyses which must be available: • One-sample Goodness-of-Fit o Chi-Square o Kolmogorov o Lilliefors o Runs • Paired Samples o Sign o Wilcoxon Signed-Rank o Hodges Lehman Estimates o Permutation o McNemar - Conditional o McNemar - Unconditional o Marginal Homogeneity • Two Independent Samples o Wilcoxon-Mann-Whitney o Hodges Lehman estimates o Normal Scores o Savage Scores o Siegel-Tukey o Ansari-Bradley o Klotz o Mood o Conover o Permutation o Logrank o Wilcoxon-Gehan o Kolmogorov-Smirnov o Wald-Wolfowitz Runs • K Related Samples o Friedman o Kendall's W o Cochran's Q o Quade o Page • K Independent Samples o Median o Kruskall-Wallis o Normal Scores o Savage o ANOVA with General Scores o Jonckheere-Terpstra o Linear by Linear o Logrank o Wilcoxon-Gehan o Tarone and Ware Trend • One-Sample Rates and Proportions o Binomial o Blyth-Still- Cassella CI for binomial proportions o Blaker CI for binomial proportions o Multinomial o Poisson CI • Poisson Rates o Homogeneity of Relative Risks o CI on Common Relative o Trend in C Ordered Poisson Rates • Two Independent Binomials o Fisher's Exact o Pearson's Chi-square o Likelihood Ratio o CI on Odds Ratio o Barnard's Test for Superiority o Tests of Non-inferiority o Tests of Equivalence o CI on Difference of Proportions o CI on Ratio of Proportions • Two Related Binomials o McNemar's test o CI on odds Ratio o Test for Superiority o Tests of Non-inferiority o Tests of Equivalence o CI on Difference of Proportions • Stratified 2x2 Tables o Homogeneity of Odds Ratios o CI on Common Odds Ratios • C Ordered Binomials (with or without strata) o Cochran-Armitage Trend o Permutation with General Scores o Trend Test for Clustered Data o Test for Interaction Across Strata • Two Ordered Multinomials (with or without strata) o Wilcoxon-Mann-Whitney o Savage Scores o Normal Scores o Permutation with General Scores o Test for Interaction Across Strata • Unordered RxC Table o Pearson's ChiSquare o Likelihood Ratio o Fisher-Freeman-Halton • Single Ordered RxC Table o Kruskal-Wallis o Normal Scores o Savage o ANOVA with Arbitrary Scores • Doubly Ordered RxC Table • Jonckheere-Terpstra • Linear by Linear Association • Stratified RxC Tables o Unordered RxC Table o Single Ordered RxC Table o Doubly Ordered RxC Table • Correlated Categorical Data o C Binomial Population o Test of Correlation o Test for Trend o Multiple Binary Outcomes o Test for Trend • Measures of Association (nominal) o Contingency Coefficients o Goodman-Kruskal-Tau o Uncertainty Coefficient • Measures of Association (ordinal) o Pearson's Correlation o Spearman's Correlation o Kendall's Concordance o Kendall's Tau and Somers' D o Gamma Coefficient • Measures of Agreement o Cohen's Kappa o Weighted Kappa • Power & Sample Size o One Binomial o Paired Binomials:Difference o Two Binomials:Difference o Superiority (conditional) o Non-inferiority o Equivalence o K ordered Binomials • Two Ordered Multinomials (power) o Superiority (unconditional) o Two Binomials: Ratio o Non-inferiority Equivalence o Superiority (unconditional) o Two Ordered Multinomials o Wilcoxon Ranksum o Savage Scores o Normal Scores o Permutation with General Score 4. A software package/component for exact logistic regression, which includes the following analyses and capabilities: • Perform regression analysis for continuous, binary, polytonomous and count data. • Apply advanced regression techniques to data sets with missing values. • Accurately fit general linear models in cases of missing categorical covariates (models include Logit, Probit, CLoglog, Poisson and Normal.) • Handle large data sets using exact methods, Monte Carlo sampling and Markov Chain Monte Carlo sampling. • Methods to include: Firth's PMLE procedure; the calculation of mid-p corrected confidence intervals for a variety of models; best subset selection in binary logistic regression; the force inclusion of variable to the best subsets; and profile likelihood confidence intervals for parameters of binary logistic regression. • ROC curves for logistic models 5. Specialized adaptive dose-finding trial design software package/component for Phase I/II designs, including validated statistical and simulation methods for the following: • Frequentist methods o Anova o Up and Down o t-test based Up and Down o Maximizing • Bayesian methods o Normal Dynamic Linear Model (NDLM) o Four Parameter Logistic (4PL) o Emax • R code support • Simulation tools • Visualization tools • Two-stage Bayesian and Frequentist designs for adaptively dropping doses • Early stopping for futility by conditional power in frequentist designs • Patient level simulation data • Plots o Dose response curves o Distribution of subjects o Subject response o Mean squared error o Estimated means/proportions o Target doses MCMC diagnostics o Credible intervals Components 1-5 may be separate software programs but should be interoperable and share a common user interface wherever possible. We do not have particular preferences for vendor selection. However, since the manufacturer sells at the same price to vendors and customers, we would expect a single bid result from putting the purchase out for bids. 6.VENDOR RESPONSIBILITIES Vendor will provide software, license files, upgrades, as well as annual maintenance and support. Delivery method can be either via CD/DVD or download. 7.PERIOD OF PERFORMANCE September 7, 2016 - September 6, 2017 (base) September 7, 2017- September 6, 2018 (option year) 8.0 Evaluation Criteria The Government will select the bidder whose offer best conforms to the solicitation and is most advantageous and provides the best value to the Government. The ability to provide the requested chemical simulation software and support is the most important factor. If proposals are equal in their technical merit, lowest price will become the determining factor. 9.Instruction to quoters: The quoters shall submit a technical volume and a pricing volume. Each volume should include the following; Volume One Technical • Shall not exceed 10 pages in length • Lowest priced technically acceptable. Vendor can affirmatively demonstrate they can meet the requirements as stated in sections A-E Volume two pricing: • Unlimited number of pages • Separate pricing for base year with all required software • Separate pricing for option year one with all required software The quoters shall include a completed copy of the provision FAR52212-3 Oferror Representation and Certifications-Commercial Items. ( October 2010) which can accessed@https://orca.bpn.gov The quoters shall comply with the provision at FAR 52.212-1(b) and submit and electronic copy to Karen Conroy (karen.conroy@fda.hhs.gov) Quoters responding to this RFP must be registered with SAM ( System Acquisition management)at http:www.sam.gov Quoters must address the following FAR clauses FAR 52.212-4 Contract Terms and Condition Commercial Items, FAR 212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items. Far provision and clauses may be found at http://ww.gov/far/index.html 10.Provisions and clauses Section 508 Accessibility Standards: • 1194.21 Software Publications and operating systems • 1194.31 Functional performance criteria • 1194.41 Information, Documentation, and Support. The following HHSAR clauses are incorporated by reference: • 352.201-Definitions ( Jan. 2006) • 352.270-12 Tobacco Free Facilities • 352-270-19 Electronic Information & Technology Accessibility These clauses may be downloaded from http://www.hhs.gov/oamp/policies/hssar.doc 52.211-6 Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the quoters plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the quoter or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the quoter clearly indicates in its offer that the product being offered is an "equal" product, the quoter shall provide the brand name product referenced in the solicitation. (End of provision) FAR 52.217-9 Option to Extend the Terms of the Contract Submission must be received via email August 22, 2016 by 1200pm eastern standard time. Questions no later than August 17, 2016. This is a firm fixed priced order. 11.Place of Performance: FDA/Center for Drug Evaluation & Research 10903 New Hampshire Ave. Silver Spring MD 20903 12. Primary Point of Contact: Karen Conroy Contract Specialist Karen.conroy@fda.hhs.gov Phone: 781-578-7452
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/fDA-SOL-16-1163455/listing.html)
- Place of Performance
- Address: FDA/Center for Drug Evaluation & Research, 10903 New Hampshire Ave., Silver Spring, MD, United States
- Record
- SN04222267-W 20160814/160812235209-d855b46852f6ad101592d651c6ac8d9c (fbodaily.com)
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