TurboRegsTM is an essential regulatory document authoring, submission and review system created to support pharmaceutical/biotech companies and investigative sites.
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Effective as of Sep 1, 2019
Welcome to the TurboRegsTM service, a collaborative regulatory document tool to facilitate and expedite processing between sponsor or sponsor delegate and investigative site. The following terms and conditions of use (together with any documents referred to herein, the “ Agreement”) apply to your use of the TurboRegs application located at www.turboregs.com (“TurboRegs”). You must acknowledge you have read and agree to the terms and conditions of this Agreement prior to creating an account with TurboRegs. If you do not agree to the terms and conditions of this Agreement, you may NOT use TurboRegs.
This Agreement is a legally binding agreement between you and Sharma Consulting, a New Jersey LLC (“Sharma Consulting”, “ we,” or “us”), the owner of TurboRegs. By creating an account with TurboRegs, you signify that you agree to this Agreement and agree to receive notices from and otherwise transact business with Sharma Consulting electronically. You further agree that you have read, understand and consent, without limitation, to the information disclosed in the TurboRegs privacy policy (the “ Privacy Policy”), which is incorporated herein by reference. You further confirm that you are 18 years of age or more, that you have your residence in the United States, that any registration information that you submit to TurboRegs is true, accurate and complete, and that you will update such information in order to keep it current. If you are using this website on behalf of your employer, you represent that you are authorized to accept these terms and conditions on your employer’s behalf.
TurboRegs may modify or amend this Agreement at any time at our sole discretion. Changes will be communicated to you by posting a new version of the Agreement on the TurboRegs website at www.turboregs.com/terms or as otherwise determined by us in our sole discretion. Your continued use of TurboRegs after such notification of changes to this Agreement will constitute your acceptance of such changes. You may also be asked to re-acknowledge and reaccept this Agreement following certain material changes.
You can create an account with TurboRegs by visiting www.turboregs.com. You will provide an E-mail address, and will then will be prompted to set up your profile, including a user information and password (the “ Credentials”). These will be your Credentials for accessing TurboRegs. You agree that Sharma Consulting may use your Credentials to authenticate you on TurboRegs. You, not Sharma Consulting, shall be responsible for maintaining and protecting your Credentials and your Sensitive Information (as defined in Section 1.B of the Privacy Policy). If your contact information or other information relating to your account changes, you must notify us promptly and keep your information current. You are responsible for all activity on TurboRegs using your Credentials, including use by others to whom you have given your Credentials, whether or not you authorized such activity. You should immediately notify us of any unauthorized use of your account or if your E-mail or password has been hacked or stolen. If you discover that someone is using your password or account without your consent, or you discover any other breach of security, you agree to notify us immediately at help@turboregs.com
Subject to your compliance with the terms and conditions of this Agreement, you are granted a limited, non-exclusive, non-transferrable, and revocable license to make use of TurboRegs. You do not have a right to transfer or sublicense your rights under this Agreement. Third party components included in TurboRegs are licensed to you either under this Agreement or under the relevant third party component license terms, as applicable. In addition, certain open-source software included in TurboRegs is licensed to you pursuant to applicable open-source licenses. Your use of the licenses described herein is subject to the restrictions set forth in Section 9 below. Sharma Consulting reserves all rights not expressly granted herein.
Use of TurboRegs requires you to electronically submit a suite of forms (the “Regulatory Packet”), which will be used to produce and complete a Statement of Investigator Form FDA 1572 to comply with 21 CFR 312.53(c). The Regulatory Packet includes, among other forms, curriculum vitae of listed personnel, medical licenses of listed personnel, financial disclosures in sponsor by listed personnel, IRB Membership list or DHHS#, local lab normal range, local lab certification, and local lab director curriculum vitae. For more information about information collected, you are directed to the Privacy Policy [LINK].
You agree that you will not upload or submit any information that you do not have the legal right to upload or submit, including without limitation Sensitive Information that contains third-party copyrighted material used without permission or Sensitive Information that violates other third-party proprietary rights.
Content displayed on TurboRegs’ website (including, but not limited to, original works of authorship, text, graphics, logos, button icons, images, audio clips, data compilations, and software, and the compilation thereof) is the exclusive property of Sharma Consulting, our affiliates, our partners or our licensors, and is protected by patents, trademarks, service marks, copyrights, trade secrets or other intellectual property rights and laws, as applicable. You agree to abide by and maintain all copyright and trademark notices, information, and restrictions contained in any content accessed through TurboRegs.
The trademarks, logos, slogans, and service marks displayed on the TurboRegs website (collectively, the “Trademarks”) are the registered or unregistered marks of Sharma Consulting, our affiliates, our licensors or our partners, in the United States and other countries, and are protected by United States and international trademark laws. All other trademarks not owned by us, our affiliates, our partners or our licensors that appear on TurboRegs are the property of their respective owners, who may or may not be affiliated with or connected to Sharma Consulting. Except as set forth herein, or as required or permitted under applicable law, no portion of the TurboRegs website may be used, reproduced, duplicated, copied, sold, resold, accessed, modified, or otherwise exploited, in full or in part, for any purpose without our prior written consent.
By establishing an account with us, you grant permission for TurboRegs to contact you at your e-mail address. To stop receiving our marketing emails, send an E-mail to us at support@TurboRegs.com or follow the opt-out procedures set forth in such marketing emails. Please note that TurboRegs will still need to communicate with you via email regarding your transactions and other account related issues, and that these emails are not marketing emails and are not eliminated through the foregoing opt-out procedures.
You hereby agree to that TurboRegs provides the site as a location for you to execute the documents relating to the Regulatory Packet. When you execute your documents through TurboRegs, only you have rights and duties with respect to such documents. TurboRegs is not a party to any agreement, and shall not have any liability or responsibility whatsoever with respect to the validity or enforceability of any documents. The sole customer support function provided by TurboRegs is to answer questions regarding the functions of the site.
By delivering to TurboRegs copies of documents, you are authorizing TurboRegs to imprint thereon your signature and to distribute the executed version of such documents to the appropriate party. TurboRegs will not make any other use of such documents without your prior written authorization.
By signing documents on TurboRegs, you are consenting to electronic signatures. You are not required to use TurboRegs to execute documents. To withdraw your consent to electronic transactions and electronic signatures, stop using TurboRegs or print and sign your documents manually. Any decision to consent or not consent to current or future document execution does not have an effect on the legality of documents previously executed on TurboRegs.
ANY STATEMENTS MADE BY TURBOREGS ABOUT THE VALIDITY OF ELECTRONIC SIGNATURES ARE GENERAL IN NATURE AND ARE NOT INTENDED, AND SHOULD NOT BE CONSTRUED, AS LEGAL ADVICE. TURBOREGS HEREBY DISCLAIMS ANY RESPONSIBILITY FOR ENSURING THAT DOCUMENTS ELECTRONICALLY EXECUTED THROUGH TURBOREGS ARE VALID OR ENFORCEABLE UNDER THE LAWS OF ANY PARTICULAR STATE OR OTHER JURISDICTION. IF YOU WISH TO VERIFY THE VALIDITY OR ENFORCEABILITY OF ELECTRONIC SIGNATURES YOU SHOULD CONSULT A LICENSED ATTORNEY FOR APPROPRIATE LEGAL ADVICE.
You may use TurboRegs only for lawful purposes and in accordance with this Agreement. You are responsible for all of your activity in connection with TurboRegs. Any unauthorized use of TurboRegs by you or anyone under your control terminates the limited license set forth in Section 4 above, without prejudice to any other rights and remedies provided herein. For the avoidance of doubt, you agree that you may not (without limitation):
TurboRegs maintains an audit trail of all information processed through the application. An audit trail is a chronological record of the sequence of actions and events that occur within the application, and in particular within a specific Regulatory Packet. Audit trails include, among other things, recordation of creations, modifications and deletions, automatic time stamps, identification and prevention of modification. Audit trails are automatically added every time an action is taken within the application and cannot be modified.
As consideration for your rights under this Agreement, you agree that Sharma Consulting has a right to allow TurboRegs to utilize the processor, bandwidth and storage hardware on your computer or other relevant device for the limited purpose of facilitating the communication and transmission of data to you and other TurboRegs users, and to facilitate the operation of the network on which TurboRegs runs. You are referred to the settings of your device for additional information relating to device performance in connection with your use of TurboRegs.
This Agreement will become effective immediately upon your creation of a TurboRegs account and acceptance of this Agreement by checking the box marked “I have read and agree to the ‘Terms and Conditions of Use/Privacy Policy’” prior to logging in to TurboRegs for the first time, and will remain effective until cancellation of your account by you or termination by Sharma Consulting pursuant to this Agreement. You may cancel your TurboRegs account at any time by sending an E-mail to [help@turboregs.com]. Sharma Consulting reserves the right to terminate this Agreement or suspend your TurboRegs account at any time in case of unauthorized, or suspected unauthorized use of TurboRegs whether in contravention of this Agreement or otherwise. If Sharma Consulting terminates this Agreement, or suspends your account for any reason, Sharma Consulting shall have no liability or responsibility to you.
Your use of TurboRegs is at your sole risk. The services provided by TurboRegs are provided on an “as is” and “as available” basis. To the fullest extent possible under applicable law, Sharma Consulting disclaims and gives no warranty, express or implied, including without limitation any warranty as to the quality, accuracy and availability or fitness for a specific purpose of TurboRegs or warranty of title or non-infringement.
Sharma Consulting does not warrant that: (i) the service will meet your specific requirements; (ii) the service will be uninterrupted, timely, secure, or error-free; (iii) the results that may be obtained from the use of the service will be accurate or reliable; (iv) the quality of any products, services, information, or other material obtained by you through the service will meet your expectations; OR (v) any errors in the service will be corrected.
You agree that Sharma Consulting will not be responsible, under any circumstances, for: (a) inability to use TurboRegs; (b) loss of profits; (c) business interruption; (d) corruption of files; (e) loss of business information; (f) loss of data; (g) service interruption; (h) computer viruses or device failure; (i) pecuniary loss; (j) unauthorized access to or alteration of your transmissions or data; (k) statements or conduct of any third party; (l) loss of communication between TurboRegs and any third party multimedia; or (m) any other events beyond our control.
FURTHER, TO THE MAXIMUM EXTENT PERMITTED BY LAW SHARMA CONSULTING WILL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING LOST PROFITS) RELATED TO TURBOREGS REGARDLESS OF THE FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL OUR MAXIMUM AGGREGATE LIABILITY EXCEED ONE HUNDRED DOLLARS ($100).
You agree to defend, indemnify and hold harmless Sharma Consulting, its affiliates and licensors and their respective officers, directors, employees, contractors, agents, licensors and suppliers from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses or fees (including but not limited to reasonable attorneys’ fees) resulting from your violation of any laws or regulations, this Agreement, or your use of TurboRegs.
Sharma Consulting will make reasonable efforts to keep TurboRegs operational. However, certain technical difficulties or maintenance may, from time to time, result in temporary interruptions. Sharma Consulting reserves the right at any time and from time to time to modify or discontinue, temporarily or permanently, functions and features of TurboRegs with or without notice.
With respect to any dispute regarding TurboRegs or this Agreement, your rights and obligations and all actions contemplated by this Agreement shall be governed by the laws of the State of New York, as if the Agreement were a contract wholly entered into and wholly performed within New York. Any dispute relating in any way to TurboRegs shall be submitted to confidential arbitration in New York, except that, to the extent you have in any manner violated or threatened to violate our intellectual property rights, we may seek injunctive or other appropriate relief in New York, and you consent to exclusive jurisdiction and venue in such courts. Arbitration under this agreement shall be conducted under the rules then prevailing of the American Arbitration Association. The arbitrator’s award shall be binding and may be entered as a judgment in any court of competent jurisdiction. To the fullest extent permitted by applicable law, no arbitration under this Agreement shall be joined to an arbitration involving any other party subject to this Agreement, whether through class arbitration proceedings or otherwise.
You agree that Sharma Consulting has a right to collect and process your personal information in accordance with the Privacy Policy, the terms of which are incorporated herein by reference.
Neither this Agreement nor any content, materials or features of TurboRegs create any partnership, joint venture, employment, or other agency relationship between you and Sharma Consulting. You may not enter into any contract on our behalf or bind us in any manner.
Sharma Consulting may assign this Agreement or any part of it without restrictions. You may not assign this Agreement or any part of it to any third party.
This Agreement, which includes by reference the Privacy Policy, constitutes all the terms and conditions agreed upon between you and Sharma Consulting and supersedes any prior agreements in relation to the subject matter of these Agreements, whether written or oral. Any additional or different terms or conditions in relation to the subject matter of these Agreements in any written or oral communication from you to Sharma Consulting are void. You agree and accept that you have not accepted the terms and conditions of this Agreement in reliance of or to any oral or written representations made by Sharma Consulting not contained in this Agreement.
Should any provision of this Agreement be held invalid or unenforceable, for any reason or to any extent, such invalidity or enforceability shall not in any manner affect or render invalid or unenforceable the remaining provisions of this Agreement and TurboRegs shall be enforced to the extent permitted by law.
If you have any questions concerning TurboRegs or this Agreement, please let us know by sending an E-mail to info@turboregs.com.
Copyright © 2019 Sharma Consulting LLC. All rights reserved.
Sharma Consulting LLC, 102 Christopher Columbus Dr., Apt 909, Jersey City, NJ 07302
Effective as of Sep 1, 2019
Sharma Consulting Corporation, a New York corporation (“Sharma Consulting”, “we” or “ us”), develops and provides TurboRegs™, a collaborative regulatory document tool between sponsor and investigative site. In order to allow investigative sites to create, update, track and store FDA form 1572s with supplemental documentation for clinical trial initiation and compliance, Sharma Consulting will require users to upload certain sensitive information and will automatically collect other information in connection with your use of TurboRegs (unless defined herein, all capitalized terms shall have the meaning set forth in the TurboRegs Terms and Conditions of Use). This privacy policy (the “ Privacy Policy”) describes our privacy practices and what information we may collect from you and what we will and will not do with that information.
A. User Information. When you create a TurboRegs account is created for you, we will request and you will provide us with certain information such as your name, discipline, contact names, postal addresses, phone numbers, E-mail addresses, and the URL from which you are signing into TurboRegs.
B. Regulatory Packet. Further Use of TurboRegs requires you or your sponsor to electronically submit a suite of forms (the “Regulatory Packet”), which will be used to produce and complete a Statement of Investigator Form FDA 1572 to comply with 21 CFR 312.53(c). The Regulatory Packet includes, among other forms, curriculum vitae of listed personnel, medical licenses of listed personnel, financial disclosures in sponsor by listed personnel, IRB Membership list or DHHS number, local lab normal range, local lab certification, and local lab director curriculum vitae.
Necessarily, the Regulatory Packet will include sensitive personal, professional, financial and other data typically provided in Form FDA 1572 (the “Sensitive Information”). All Sensitive Information will be uploaded to TurboRegs’ servers for access by you or your sponsor and shall be stored and/or backed-up on TurboRegs’ secure servers or on servers of trusted third parties as necessary, and in accordance with TurboRegs’ then-current storage practices.
As part of the Regulatory Packet, TurboRegs does not require or request that users provide social security or tax identification numbers. If users choose to include such information in documents included in the Regulatory Packet, TurboRegs will take all necessary precautions to protect and prevent unauthorized disclosure or access to such information pursuant to this Privacy Policy. Should you choose to provide such information as part of a Regulatory Packet, you are consenting to transmission as set forth herein.
We will not share Sensitive Information with others without your permission. We are working to offer the ability to export data and other information from your account to a readable format at any time during or after the Term of this Agreement.
C. Automatic Collection. In addition, when you use TurboRegs, we will automatically receive information relating to your use of TurboRegs, including all data inputted into TurboRegs’ fields, all inputted and uploaded Sensitive Information (as defined in Section 1.B above), your internet protocol address, data relating to performance of your network and computer or device, language and identifying information, and your operating system.
D. Cookies. We may also store information about you using cookies (files which are sent by us to your computer or other access device) that we can access when you visit TurboRegs. We do this to help improve the user experience of TurboRegs. If you want to delete any cookies that are already on your computer or device, please refer to the instructions for your file management software to locate the file or directory that stores cookies. Please note that by deleting our cookies or disabling future cookies you may not be able to access certain areas or features of TurboRegs.
E. Additional. We may also, from time to time, collect information from you through surveys in which you may choose to participate.
F. Our Usage. We will use your information and the data we collect: (i) to prepopulate an FDA form 1572 with forms to supplement a complete Regulatory Package; (ii) to communicate with you concerning your account, customer service issues and TurboRegs; (iii) to personalize and improve the services provided through TurboRegs; (iv) to ensure the technical functioning of TurboRegs; (v) to develop new products and services; and (vi) as otherwise stated in this Privacy Policy.
Unless you give us your explicit approval and except as outlined in Section 1 above, we will only share your information as is necessary to:
a. Enforce the TurboRegs Terms and Conditions of Use.
b. Comply with laws, regulations and any applicable court orders or to respond to requests from governmental or administrative bodies or to comply with litigation matters or other legal process, and/or to establish or exercise our legal rights or defend against legal claims.
c. Allow for a change of ownership of TurboRegs (including but not limited to an acquisition by or merger with another company) and related transfer of all personal information to the new owner in which case any information remains protected in accordance with this Privacy Policy. See Section 10 below.
d. Allow us to use a third party to perform surveys measuring your experiences and use of TurboRegs (not permitting the third party to use your Sensitive Information for any other purpose).
e. Allow us to share aggregated statistics and information with parties with whom we do business.
TurboRegs may also use certain trusted third party companies and individuals to help provide, analyze, and improve TurboRegs (including but not limited to data storage, maintenance services, database management, web analytics, payment processing, and improvement of TurboRegs’ features). These third parties may have access to your information only for purposes of performing these tasks on TurboRegs’ behalf and under obligations similar to those in this Privacy Policy. As of the date this policy went into effect, Sharma Consulting uses Amazon Web Services to store and manage your information.
Should Sharma Consulting transfer and process your information on a server outside the United States, we will use our best efforts to do so in accordance with this Privacy Policy and applicable law. By approving the Privacy Policy, you consent to such transfer of your personal information.
We know the value of your information, and we take security extremely seriously. We take a number of steps to keep your information secure from unauthorized access. For example, we ask you to use a unique and strong password and not to share this information with anyone. In addition, we use secure encryption with open SSL and x509 certificates to limit access to the systems that store your personal information. Further, we respect and comply with applicable laws and regulations on data protection. Additionally TurboRegs makes every reasonable effort to maintain compliance with the requirements of 21 CFR Part 11, including but not limited to, the internal security and audit trail requirements thereof, as discussed in more detail in Section 10 of the TurboRegs Terms and Conditions of Use.
You are responsible for maintaining the security of your user access name and related password. While we work extremely hard to safeguard your information once we receive it, please be aware that no transmission of data over a public network or storage of data on a cloud network can be guaranteed to be 100% secure.
You can access and update by sending a request to help@turboregs.com. We will endeavor to respond to your request upon verification of your identity within a reasonable period of time, and to the maximum extent practical.
Sharma Consulting reserves the right to make changes to this Privacy Policy in its sole discretion. If we make any changes to this policy we will notify you by posting the new version of the policy at www.turboregs.com/privacy. It is your sole responsibility to periodically monitor the website for such postings. You may also be asked to re-acknowledge and reaccept this policy following any material changes.
Please note that by accepting the TurboRegs Terms and Conditions of Use, you consent to the collection and processing of your personal information as described herein. Your continued use of TurboRegs following the posting or other notice of changes to this Privacy Policy will constitute an acceptance of such changes.
TurboRegs may contain links to third party websites. Please be aware that we are not responsible for the privacy practices of other websites. This Privacy Policy applies only to the information we collect through TurboRegs. We encourage you to read the privacy policies of other websites you link to from our website or otherwise visit.
Subject to Section 7 of the TurboRegs Terms and Conditions of Use, you may opt out of receiving future E-mail communications from us by E-mailing us at support@turboregs.com.
In the event that TurboRegs becomes owned or controlled by other individuals or entities, the information we have collected about you through TurboRegs or otherwise may be transferred to such other individuals or entities. In such an event, this Privacy Policy will continue to apply to the information gathered about you through TurboRegs until you are notified otherwise or a change is made to this policy and posted or notified as provided above.
If you have any concerns, questions or thoughts on how we can improve the Privacy Policy, please let us know by sending an E-mail to help@turboregs.com.
Copyright © 2019 Sharma Consulting LLC. All rights reserved.
Sharma Consulting LLC, 102 Christopher Columbus Dr. Apt 909, Jersey City, NJ 07302