Attach to Form 990 or 990-EZ.
Information about Schedule O (Form 990 or 990-EZ) and its instructions is at| Return Reference | Explanation |
|---|---|
| FORM 990, PART III, LINE 2 | TRANSCELERATE CURRENTLY HAS 12 INITIATIVES WHICH SHARE THE GOALS OF INCREASING EFFICIENCIES IN CLINICAL TRIALS, ENHANCING PATIENT SAFETY & ACCELERATING DEVELOPMENT TIMELINES. IN 2014, TRANSCELERATE APPROVED THREE ADDITIONAL INITIATIVES: CLINICAL DATA TRANSPARENCY: IN RESPONSE TO REGULATORY AGENCIES' PUSH FOR GREATER CLINICAL DATA TRANSPARENCY, TRANSCELERATE IS DEVELOPING A POSITION ON THE BEST AND MOST EFFICIENT METHODS FOR REDACTING PRIVACY INFORMATION FOUND IN CLINICAL STUDY REPORTS, AND AN APPROACH FOR THE ANONYMIZATION OF PATIENT LEVEL DATA SHARED WITH THE BROADER HEALTH CARE COMMUNITY. QUALITY MANAGEMENT SYSTEM: DEVELOP A FRAMEWORK SPECIFICALLY FOR CLINICAL RESEARCH TO IMPROVE THE QUALITY AND EFFICIENCY OF CLINICAL TRIALS. A QMS WILL ENHANCE PATIENT SAFETY BY IMPROVED QUALITY, ASSURE DATA INTEGRITY, MINIMIZE DELAYS IN CLINICAL TRIALS, AND BRING DRUGS TO MARKET MORE QUICKLY. PLACEBO / STANDARD OF CARE DATA SHARING: CURRENTLY, NO VEHICLE EXISTS TO MAXIMIZE VALUE OF CLINICAL DATA COLLECTED HISTORICALLY TO IMPROVE STUDY DESIGN, INTERPRET SAFETY SIGNALS CONTEXTUALLY AND IMPROVE SUBJECT RECRUITMENT. TRANSCELERATE IS SEEKING TO ESTABLISH A SOLUTION TO SHARE PLACEBO AND STANDARD OF CARE (SOC) DATA ACROSS PARTICIPATING MEMBER COMPANIES. THIS COULD LEAD TO IMPROVED CLINICAL TRIAL DESIGN, FASTER CLINICAL TRIAL EXECUTION, ENABLE A BETTER UNDERSTANDING OF DISEASES, AND IMPROVE THE PATIENT EXPERIENCE IN A CLINICAL TRIAL. |
| FORM 990, PART VI, SECTION A, LINE 4 | SECTION 2.01(A)(III) OF THE BYLAWS PREVIOUSLY PROVIDED THAT: "TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION OR BE AN EXTERNAL PARTNER OF PHARMACEUTICAL COMPANIES IN CLINICAL TRIALS." THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE THAT: "TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION." IN SECTION 2.01(B) OF THE BYLAWS, THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO ADD THE FOLLOWING LANGUAGE: "FOR PURPOSES OF DETERMINING AN APPLICANT'S MEMBERSHIP TIER, THE BOARD OF DIRECTORS OR ITS DESIGNEES SHALL CONSIDER AND TAKE INTO ACCOUNT THE ANNUAL RESEARCH AND DEVELOPMENT BUDGET FOR NOT ONLY THE PARTICULAR COMPANY APPLYING FOR MEMBERSHIP, BUT ALSO ANY ENTITY CONTROLLING, CONTROLLED BY, OR UNDER COMMON CONTROL WITH THE APPLICANT. (AND IN THIS CONTEXT, "CONTROL" SHALL MEAN DIRECT OR INDIRECT OWNERSHIP OF OR THE RIGHT TO EXERCISE: (I) GREATER THAN FIFTY PERCENT (50%) OF THE OUTSTANDING SHARES OR SECURITIES ENTITLED TO VOTE FOR THE ELECTION OF DIRECTORS OR SIMILAR MANAGING AUTHORITY OF THE SUBJECT ENTITY; OR (II) GREATER THAN FIFTY PERCENT (50%) OF THE OWNERSHIP INTEREST REPRESENTING THE RIGHT TO MAKE DECISIONS FOR THE SUBJECT ENTITY.)" IN SECTION 2.04(G) OF THE BYLAWS, THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO ADD THE FOLLOWING LANGUAGE: "MEMBERS MAY VOTE BY PROXY VIA TELEPHONIC OR ELECTRONIC MEANS AS PERMITTED BY THE BOARD." SECTION 3.02 OF THE BYLAWS PREVIOUSLY PROVIDED THAT: "THE INITIAL BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY (20) MEMBERS; PROVIDED THAT: A MINIMUM OF TWELVE (12) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE CHARTER MEMBERS (AS DESIGNATED AS SUCH BY THE BOARD OF DIRECTORS OF THE CORPORATION IN ITS SOLE DISCRETION) ("CHARTER MEMBER DIRECTORS") AND, IF SUCH NUMBER IS INCREASED IN THE FUTURE, THE REMAINDER OF SUCH SEATS RESERVED MAY BE FILLED BY TIER I MEMBERS THAT ARE NOT CHARTER MEMBERS ("TIER I DIRECTORS"); AT LEAST SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS ("TIER II DIRECTORS"); ONE (1) SEAT SHALL BE FILLED BY A DIRECTOR WHO IS A REPRESENTATIVE OF THE ASSOCIATE MEMBERS ("ASSOCIATE MEMBER DIRECTOR"); AND ONE (1) SEAT SHALL BE FILLED BY THE CHIEF EXECUTIVE OFFICER OF THE CORPORATION "CEO DIRECTOR"). THE BOARD SEATS RESERVED FOR THE TIER I MEMBERS, INCLUDING THE CHARTER MEMBERS, SHALL AT ALL TIMES REPRESENT AT LEAST 55% OF THE TOTAL NUMBER OF DIRECTORS OF THE BOARD. IN THE EVENT THAT THE NUMBER OF DIRECTORS IS INCREASED TO MORE THAN SEVENTEEN (17) MEMBERS, THEN THE BOARD SEATS RESERVED FOR THE TIER I MEMBERS, INCLUDING THE CHARTER MEMBERS, AND THE BOARD SEATS RESERVED FOR THE TIER II MEMBERS SHALL BE INCREASED IN THE SAME RATIO AS SET FORTH ABOVE. THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE: "THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY (20) MEMBERS; PROVIDED THAT (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS (AND EACH CHARTER MEMBER HAS DISCRETION TO APPOINT ITS OWN REPRESENTATIVE TO THE BOARD OF DIRECTORS) ("CHARTER MEMBER DIRECTORS"); (II) UP TO TWO (2) ADDITIONAL SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE NOT CHARTER MEMBERS ("AT LARGE TIER I DIRECTORS)(CHARTER MEMBER DIRECTORS AND AT LARGE TIER I DIRECTORS COLLECTIVELY REFERRED TO AS "TIER I DIRECTORS"); (III) UP TO SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS ("TIER II DIRECTORS"); (IV) ONE (1) SEAT SHALL BE FILLED BY A DIRECTOR WHO IS A REPRESENTATIVE OF THE ASSOCIATE MEMBERS ("ASSOCIATE MEMBER DIRECTOR"); AND (V) ONE (1) SEAT SHALL BE FILLED BY THE CHIEF EXECUTIVE OFFICER OF THE CORPORATION ("CEO DIRECTOR"). THE BOARD SEATS RESERVED FOR THE TIER I MEMBERS, INCLUDING THE CHARTER MEMBERS, SHALL AT ALL TIMES REPRESENT AT LEAST 55% OF THE TOTAL NUMBER OF DIRECTORS OF THE BOARD. IN THE EVENT THAT THE NUMBER OF DIRECTORS IS INCREASED, THEN THE BOARD SEATS RESERVED FOR THE TIER I MEMBERS, INCLUDING THE CHARTER MEMBERS, AND THE BOARD SEATS RESERVED FOR THE TIER II MEMBERS SHALL BE INCREASED IN THE SAME RATIO AS SET FORTH ABOVE." IN SECTION 3.09 OF THE BYLAWS, THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO ADD THE FOLLOWING LANGUAGE: "SUCH WRITTEN CONSENT(S) MAY BE MADE BY ELECTRONIC TRANSMISSION, INCLUDING E-MAIL." |
| FORM 990, PART VI, SECTION A, LINE 6 | THE MEMBERS OF THE CORPORATION CONSIST OF SUCH FIRMS AND CORPORATIONS THAT ARE APPROVED FOR MEMBERSHIP FROM TIME TO TIME BY THE BOARD OF DIRECTORS OR ITS DESIGNEES IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF THE CORPORATION. THE CORPORATION HAS THE FOLLOWING CATEGORIES OF MEMBERS: A. TIER I MEMBERS - TO BE ELIGIBLE FOR TIER I MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT IN EXCESS OF $2.5 BILLION. ELIGIBILITY FOR TIER I MEMBERSHIP IS ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. THE INITIAL TIER 1 MEMBER ARE FURTHER DEFINED AS THE "CHARTER MEMBERS. B. TIER II MEMBERS - TO BE ELIGIBLE FOR TIER II MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $2.5 BILLION BUT MORE THAN $100 MILLION. ELIGIBILITY FOR TIER II MEMBERSHIP WILL BE ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. C. ASSOCIATE MEMBERS - TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION OR BE AN EXTERNAL PARTNER OF PHARMACEUTICAL COMPANIES IN CLINICAL TRIALS. |
| FORM 990, PART VI, SECTION A, LINE 7A | THE CORPORATION'S BY-LAWS STATE THAT DIRECTORS SHALL BE ELECTED OR APPOINTED, AS APPLICABLE, ANNUALLY AT THE ANNUAL MEETING OF MEMBERS AND SHALL SERVE UNTIL THE FOLLOWING ANNUAL MEETING OF MEMBERS AND UNTIL THEIR SUCCESSORS ARE ELECTED OR APPOINTED, AS APPLICABLE, AND QUALIFIED. EACH CHARTER MEMBER SHALL HAVE THE RIGHT TO APPOINT A REPRESENTATIVE OF THE CHARTER MEMBER TO SERVE AS A CHARTER MEMBER DIRECTOR. TIER I DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER I MEMBERS, WHICH INCLUDE THE CHARTER MEMBERS. TIER II DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER II MEMBERS. THE ASSOCIATE MEMBER DIRECTOR SHALL BE ELECTED BY A PLURALITY VOTE OF THE ASSOCIATE MEMBERS. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. |
| FORM 990, PART VI, SECTION A, LINE 7B | EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER 1 MEMBERS ARE ENTITLED TO VOTE. EACH TIER II MEMBER SHALL BE ENTITLED TO ONE (1) VOTE AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER II MEMBERS ARE ENTITLED TO VOTE. ASSOCIATE MEMBERS SHALL BE ENTITLED TO NOTICE OF AND TO ATTEND MEETINGS OF THE MEMBERS BUT SHALL NOT BE ENTITLED TO VOTE AT SUCH MEETINGS, PROVIDED HOWEVER, ASSOCIATE MEMBERS SHALL HAVE THE RIGHT TO CAST ONE (1) VOTE EACH WITH RESPECT TO THE ELECTION OF THE NOMINEE TO FILL THE ASSOCIATE MEMBER BOARD POSITION. NOTWITHSTANDING THE ABOVE, IN ORDER TO BE ELIGIBLE TO VOTE, A MEMBER MUST BE IN GOOD STANDING AND ITS DUES AND ASSESSMENTS PAID IN FULL. |
| FORM 990, PART VI, SECTION B, LINE 11 | THE FINANCE COMMITTEE AND MANAGEMENT REVIEW AND APPROVE THE FORM 990. THE FORM IS THEN DISTRIBUTED TO ALL MEMBERS OF THE BOARD FOR THEIR REVIEW BEFORE FILING WITH THE INTERNAL REVENUE SERVICE. |
| FORM 990, PART VI, SECTION B, LINE 15 | THE TRANSCELERATE BOARD OF DIRECTORS PREPARES AND APPROVES THE COMPENSATION PACKAGE FOR THE CEO. THE CEO APPROVES THE COMPENSATION FOR THE HEAD OF DELIVERY EXCELLENCE AND CORPORATE AFFAIRS, ALONG WITH ALL OTHER KEY EMPLOYEES. |
| FORM 990, PART VI, SECTION C, LINE 19 | THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, AND CONFLICT OF INTEREST POLICY ARE AVAILABLE UPON REQUEST. |
| FORM 990, PART IX, LINE 11G | OUTSIDE CONTRACT - TECHNOLOGY CONSULTING SERVICES: PROGRAM SERVICE EXPENSES 991,632. MANAGEMENT AND GENERAL EXPENSES 687,220. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,678,852. CONSULTANTS -TECHNOLOGY CONSULTING SERVICES: PROGRAM SERVICE EXPENSES 2,951,074. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,951,074. CROSS WS FEES: PROGRAM SERVICE EXPENSES 2,554,022. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,554,022. MARKETING CONSULTANT - OUTSIDE CONSULTANT: PROGRAM SERVICE EXPENSES 0. MANAGEMENT AND GENERAL EXPENSES 29,000. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 29,000. |
| FORM 990, PART XI, LINE 9: | WRITE OFF SOFTWARE COSTS AND CONTRIBUTED SERVICES PREVIOUSLY RECORDED -623,602. REVERSE DEPRECIATION TAKEN ON SOFTWARE 50,000. |
| FORM 990, PART VI, SECTION B, LINE 14 | THE ORGANIZATION DOES NOT HAVE A WRITTEN DOCUMENT RETENTION AND DESTRUCTION POLICY. A DOCUMENT RETENTION AND DESTRUCTION POLICY WILL BE DEVELOPED AND ADOPTED IN 2015. |
| Software ID: | |
| Software Version: |