Pinnacle 21 Privacy Center

Pinnacle 21 is committed to protecting your privacy. Here you can find the privacy principles that guide everything we do and what we stand for as a company. If you want to know exactly what we are doing to protect the privacy of your information and to keep your information secure, you can read our Website Privacy Policy and Community Privacy Policy.

Transparency

We want our customers and users to know everything they need to know before trusting us with their sensitive data. To show you how important privacy is to Pinnacle 21, we developed Privacy Basics to help you easily understand what information we collect when you use our products, how we use it, with whom we may share it, and your choices. In case you want to know more, we also have a Privacy Policy that’s not written in legalese, so you won’t have to call your lawyer every time you want to use our products or services.

Privacy

Because we believe that truly protecting your privacy means not turning you into the product, we do not sell the information we collect about you to third parties. We will only disclose your information to third parties in the circumstances detailed in our Website Privacy Policy and Community Privacy Policy.

Security

We continually improve our security systems and invest time and resources in making sure that your data and information are kept secure. We only contract with third parties if they can demonstrate that they hold the same (or higher) security standards as we do. Because we don’t want any loose ends, we also train our employees to be privacy-savvy and to know how to safeguard your information and data.

Improvement

Why do we want to collect your information, anyway? At Pinnacle 21, we believe that there’s always room for improvement. That’s why we care about collecting your information: we want to know how our clients interact with our products so we can figure out which features they love and which ones need to be perfected, what capabilities they’d like our products to have, which features they don’t really use, etc.

Choice

We will always allow you to choose how much Personal Information you want to share with us, and you will even have the option to direct us to delete any Personal Information we have ever collected about you from our records. However, keep in mind that some of our products’ functionalities might be limited, or not work, if you decide not to share some of your Personal Information.

If you’ve ever tried to read (or wish that you could understand) a privacy policy before, you know how long and technical they tend to be. We’ve all been there, but we still don’t know anyone who has ever enjoyed it. Since you have made it this far, you probably (really) care about your privacy, so we want to make things as easy as possible for you because Pinnacle 21 was literally created to facilitate processes. These Privacy Basics are intended to give you a summary of what you absolutely need to know about our privacy practices before using our website or Pinnacle 21 Community, but if you’re feeling adventurous and would like to read our full, detailed Privacy Policy, you can click here and here. Please note that, if your business/employer has executed an agreement permitting use of the Pinnacle 21 Enterprise software-as-a-service platform, then that agreement will govern our collection and use of information while you are using Pinnacle 21 Enterprise or any of its related services. If you or your business/employer is located in the European Economic Area or Switzerland, click here for more information.

What we collect

When you visit our website or use Pinnacle 21 Community, we will collect two kinds of information: Personal Information and Non-Personal Information. Personal Information can be used to identify you, so it’s very important to us that you know what pieces of Personal Information we can collect from our customers and users. Please read the Website Privacy Policy and Community Privacy Policy to learn exactly what Personal Information and Non-Personal Information we will collect.

Examples of the Personal Information we might collect when you use our website or Pinnacle 21 Community include:

  • Your IP address;
  • Information about you that you submit to us (such as your name, email address, business address, phone number, username and password, job description, and country where you are located);
  • Contact and other information collected during your interactions with Pinnacle 21; and
  • Unique identifiers (also known as GUID) that we create.

Some of the types of Non-Personal Information we might collect when you use our website or Pinnacle 21 Community include:

  • Information about your device (such as what hardware and software you use to access our products or website);
  • Information about how you use our products or website (such as which features you use and how often, what content you access, and your language preferences); or
  • Information about your location (such as your city and state, but not your precise geographic location).

What we do with it

If you’re wondering why we bother to collect all this information in the first place, here are some examples of what we may do with it:

  • Make our website and our products work;
  • Monitor our website’s and our products’ performance;
  • Develop, support, and improve our website and our products;
  • Keep our website and our products secure;
  • Create de-identified user metrics and analytics (which we use internally for website and product development and improvement);
  • Display customized content; and
  • Communicate with our users and customers.

How we share it

Sometimes sharing is not caring, and we care. We care about your privacy and the privacy of your company. For that reason, we will not sell or disclose your Personal Information to third parties for their own marketing purposes. The only times that we might need to disclose your Personal Information to third parties are:

  • When we need to do so in order to provide our services or allow a third party to perform functions on our behalf;
  • To comply with laws and regulations, to cooperate with law enforcement, or to prevent harm to others or ourselves; or
  • In the unlikely event that our company is sold to a third party or files for bankruptcy.

Your Non-Personal Information, on the other hand, may be disclosed to our clients, business partners, independent contractors, investors, potential buyers, or other third parties, but only after it has been de-identified and grouped with information about other consumers so that it is anonymous. This means that this information cannot, under any reasonable circumstances, be used to personally identify you.

Community

Pinnacle 21 Community is an open-source tool designed to help you make sure your trial and study data is CDISC, SDTM and ADaM compliant. Pinnacle 21 Community is available to download for free from our website, subject to the open source license agreement that applies to it. It includes several tools, such as Pinnacle 21 Validator to help ensure that your data is CDISC compliant, Define.xml Generator to create metadata in standardized format, a Data Converter to generate datasets, and a ClinicalTrials.gov Miner to help you find information on all existing trials and studies. We know that your privacy is a priority to you, and we feel the same way, so we’ve developed a Privacy Policy specific to Pinnacle 21 Community users to help you understand what information we collect when you download and use our software, how we use it, and with whom we share it.

Enterprise

Pinnacle 21 Enterprise is a cloud hosted, fully managed, validated, and supported data standardization pipeline. In 2011, we created this game-changing product that has become the life science industry’s universally adopted platform. By using our unique Software-as-a-Service solution, you can make sure that the clinical and pre-clinical data you submit to FDA and PMDA is in a standardized format that will comply with their requirements, so your approval process is efficient and trouble-free. Our use of information collected through Pinnacle 21 Enterprise and/or its related services is governed by the Pinnacle 21 Enterprise agreement (or equivalent agreement) between Pinnacle 21 and your business or employer.

Website

Our website is an informational resource for our current and potential clients to learn more about who we are and what we do. Here you can join our community by participating in forums, reading our blog, and downloading Pinnacle 21 Community, the open source version of our software. You can also learn more about our company, our products and services, find open employment opportunities, subscribe to our newsletter, request a demo of Pinnacle 21 Enterprise, learn more about validation rules, access important documentation, and much more. We’re committed to protecting your privacy, so we have developed a Privacy Policy specific to our website to help you understand what information we collect when you visit this website, how we use it, and with whom we share it.

Pinnacle ID gives you the opportunity to sign up for an account with Pinnacle 21. We created Pinnacle ID as a way to stay connected with our users and clients, get to know them better, and offer them exclusive benefits. Although you are not required to create a Pinnacle ID account in order to use any of our products, doing so has many benefits, such as:

  • Allowing you to access all of our services with a unique login, including our forum, webinars and other educational resources.;
  • Allowing you full access to Pinnacle 21’s web services, including enabling automatic updates to validation engines, rules, CDISC terminologies, and external dictionaries;
  • Receiving important communications about our products;
  • Participating in our online forum, where you can interact with other users, ask questions about our products, get industry news, receive assistance with troubleshooting, give us feedback, and more; and
  • Attending Pinnacle 21 webinars, where you can learn more about our products’ features and how to maximize your use of them.

If you want to register for Pinnacle ID, click here.

Last updated: January 1, 2021

Website Privacy Policy

About this Policy

This Privacy Policy applies to the Pinnacle 21 Website at www.pinnacle21.com (the "Website"), which is owned and operated by Pinnacle 21 LLC, a Delaware limited liability company ("we," "us" or "our"). It also applies to information provided to us offline (such as through in-person interactions), but it does not apply to information we collect from our employees, vendors or contractors. By accessing or using our Website, you consent to this privacy policy.

We may update this Privacy Policy at any time by posting the latest version on this page, with or without prior notice. If we make any material changes, we will post a notice on our Website prior to the changes becoming effective. The "last updated" date at the top of this page will tell you the last time we made any changes.

If you or your business/employer is located in the European Economic Area or Switzerland, click here for more information.

What information do we collect when you visit our Website?

a) Information that you submit to us

We will collect and retain any Personal Information you provide to us through our Website. Keep in mind that Personal Information can be used to identify you. For example, we will retain:

  • Your email address if you subscribe to our newsletter;
  • Any information you submit to apply for a job at Pinnacle 21 through our career portal;
  • Any information you volunteer when posting in our forum; and
  • Your name, email address, and any other information you submit when completing our "Contact Us" form.

b) Information we gather through the use of cookies

Like most websites, our Website may sometimes use cookies (including third-party cookies) and other technologies to gather information about what you did during your visit. You can find more information about what cookies are and how we use them below. The information that our cookies collect can sometimes be used to identify you as well, which is why we refer to it as "Personal Information." For example, we may collect information about:

  • Your IP address;
  • Your device ID;
  • What web browser or device you use for visiting our Website;
  • What pages of our Website you visit;
  • What information or content you view, hover over, or click on;
  • What websites you visited before visiting ours;
  • The city and state from which you visited our Website (but not your precise geographic location); or
  • Unique identifiers we might create to identify each user.

Just so you know, this information may be collected either by us or by one of our service providers, but either way, it will be governed by this Privacy Policy.

We do not knowingly collect Personal Information from users under 18 years of age, and we do not authorize users under 18 years of age to use our services. If we learn that we have accidentally collected Personal Information from a person under the age of 18, we will promptly delete that data from our systems.

Cookies

A cookie is a piece of data that websites store on your computer when you visit; that site can then use the cookie to uniquely identify you any time you visit it again. We use cookies so we can understand information we collect about our visitors, including their usage of our Website and other websites. This information allows us to learn what features of our Website are primarily used and how many visitors our Website has, which helps us in providing a more secure and personalized experience.

The categories of cookies we use are:

  • Google Analytics (distinguishes between users)
  • Cookies that store users’ preferences
  • Session cookies that keep track of user state

You can change the settings in your browser to remove or reject cookies, but keep in mind that doing so may affect the functioning of our Website. You can learn more about how to manage cookies here.

What do we do with the information we collect?

After collecting information about your visit to our Website, we may use it to:

  • Monitor our Website: we monitor how many times our Website is visited and how it performs because we want to know how we are doing;
  • Develop our Website: our goal is to make our Website a useful resource for visitors, so we collect information about how visitors use it to be able to improve its features;
  • Keep our Website secure: data privacy and security are always our top priority, so we collect information to identify and prevent security risks in order to make sure that your information is safe;
  • Create de-identified user website analytics; or
  • Display content that is customized to your interests or preferences.

With whom do we share your information?

We do not disclose your Personal Information to anyone, except when we need to do so in order to provide our services or allow a third party to perform functions on our behalf, to comply with laws and regulations, to cooperate with law enforcement, to prevent harm to others or ourselves, and in the unlikely event that our company is sold to a third party or files for bankruptcy. Only those employees and service providers who need access to Personal Information in order to help us in running our Website will have access to it, and they are all bound by stringent confidentiality obligations that we take very seriously and are not afraid to enforce.

We may disclose other information we collect after we have de-identified it and anonymously grouped it with information we collected about all our Website visitors so that it cannot be used to identify you. We may choose to share that de-identified, anonymous information with our clients, business partners, vendors, investors, potential buyers of our company, and other third parties if we believe that such disclosure is necessary for our business purposes or to make sure that our Website is performing like we expect it to. This de-identified, anonymous information cannot be used to re-identify you, and we do not use or allow any third party to use the information we collect on our Website for targeted or behavioral advertising.

How do we keep your information safe?

Safeguarding your information is a significant priority for us. For example, we use Secure Socket Layer encryption technology to protect Personal Information, and firewalls to help prevent external access into our network. However, keep in mind that, despite our best efforts, data transmission over the Internet and data storage can never be 100% secure.

If our Website links to or integrates with third party websites, services, or apps, we will not be responsible for their data privacy and security practices or policies. Please review their privacy and security policies if you want to know how such third parties use and protect your information.

Accessing/Updating/Deleting Your Personal Information

If you would like to delete, update, or access the Personal Information we have collected from you, you can send an email to privacy@pinnacle21.com. Once we have verified your request, we will make reasonable efforts to comply with it, unless we have a legitimate interest in retaining your Personal Information as permissible under applicable law. If we do retain your information pursuant to a legitimate interest of Pinnacle 21, we will only continue to use your information in furtherance of this legitimate interest. We also reserve the right to limit or decline repeated, abusive, harassing, or otherwise unreasonable requests.

Questions?

Questions? Comments? Suggestions? We want to hear from you!
Email: privacy@pinnacle21.com
Phone: +1 (888) 507-2270
Mail: Pinnacle 21 LLC, 1777 Sentry Parkway W, VEVA 17, Suite 405, Blue Bell, PA 19422, USA

Last updated: January 1, 2021

Community Privacy Policy

About this Policy

This Privacy Policy applies to Pinnacle 21 Community ("Community"), which is owned and operated by Pinnacle 21 LLC, a Delaware limited liability company ("we," "us" or "our"). It also applies to information provided to us offline (such as through in-person interactions or through our telephone support), but it does not apply to information we collect from our employees, vendors or contractors. By downloading Community, you consent to this Privacy Policy, which supplements the Pinnacle 21 Open Source Software License and the Pinnacle 21 Website Privacy Policy.

We may update this Privacy Policy at any time by posting the latest version on this page, with or without prior notice. If we make any material changes, we will post a notice on our Website prior to the changes becoming effective. The "last updated" date at the top of this page will tell you the last time we made any changes.

If you or your business/employer is located in the European Economic Area or Switzerland, click here for more information.

What information do we collect when you download Community?

When you download Community, we collect Personal Information and non-Personal Information (depending partly on whether you sign up for Pinnacle ID or not, as fully explained below). While Personal Information can be used to identify an individual, non-Personal Information cannot. Because we respect your privacy, we will not use any non-Personal Information that we collect to try to identify you. However, if we later combine your non-Personal Information with your Personal Information, we will treat the resulting information as Personal Information and be extra careful when we store it. Just so you know, this information may be collected either by us or by one of our service providers, but either way this Privacy Policy will govern how we handle it.

The only Personal Information we may collect (and store) when you download Community is:

  • If you signed up for Pinnacle ID, information associated with your user ID, such as:
    • Name;
    • Email address;
    • Password;
    • Job type;
    • Country; and
    • Globally Unique Identifier ("GUID" - A GUID is an arbitrary ID number that a company can use to uniquely identify users of their websites or products).
  • If you haven’t signed up for Pinnacle ID, we will only collect your GUID.

Whether you have signed up for Pinnacle ID or not, your GUID will be tied to reports containing information about:

  • Performance and reliability of Community (such as the time it takes to complete a validation or a data conversion task, and how many problems you experience running Community); and
  • Community use (such as the features that you use most often, how frequently you launch the Community tools, how many records or how much data you process, what rule sets and dictionaries you use, and what issues are triggered when using different Community features).

Examples of non-Personal Information we may collect when you download Community are:

  • What web browser or device you use to download it;
  • Your language preferences; and
  • The city and state from which you downloaded Community (but not your precise geographic location).

We do not knowingly collect Personal Information from users under 18 years of age, and we do not authorize users under 18 years of age to use our services. If we learn that we have accidentally collected Personal Information from a person under the age of 18, we will promptly delete that data from our systems.

What do we do with the information we collect?

How we use the information we collect when you download Community depends on whether you have signed up for Pinnacle ID or not.

If you have not signed up for Pinnacle ID, we may use your information to:

  • Improve our products and services: we collect information to help us learn how our users interact with Community in order to figure out ways in which we could make it, and all of our products and services, better; and
  • Keep Community secure: data privacy and security are always our top priority, so we collect information to identify and prevent security risks in order to make sure that your information is safe.

If you have signed up for Pinnacle ID, we may also use your information to:

  • Create one global account: we use your Pinnacle ID to create a single account through which you can access our products and services, including our forum, webinar, and other educational resources;
  • Access Pinnacle 21 Web Services: Pinnacle ID will allow you to enable automatic updates to Community, including updates to validation engines, rules, CDISC terminologies, and external dictionaries; and
  • Communicate with Community users: we collect information to send newsletters, RSS feeds, and any other communications that our users have signed up for or otherwise agreed to receive from us; we also send account-related communications, such as welcome emails or notifications related to our software or services or your use of Community, and information regarding other Pinnacle 21 products or services that we think might interest you.

With whom do we share your information?

We may disclose your information to third parties under the following circumstances only:

  • If you have signed up for Pinnacle ID, we may disclose your Personal Information to our service providers in order to send you communications relating to our company and our software and services.
  • We may also disclose your Personal Information when we need to do so in order to provide our services or allow a third party to perform functions on our behalf, to comply with laws and regulations, to cooperate with law enforcement, to prevent harm to others or ourselves, and in the unlikely event that our company is sold to a third party or files for bankruptcy. Only those employees and service providers who need access to Personal Information in order to help us provide our services will have access to it, and they are all bound by confidentiality obligations that we take very seriously.

We may disclose other information we collect after we have de-identified it and anonymously grouped it with information we collected about other users so that it cannot be used to identify you. We may choose to share that de-identified, anonymous information with our clients, business partners, vendors, investors, potential buyers of our company, and other third parties if we believe that such disclosure is necessary for our business purposes or to make sure that Community is performing like we expect it to. This de-identified, anonymous information cannot be used to re-identify you.

How do we keep your information safe?

Safeguarding your information is a significant priority for us. For example, we use Secure Socket Layer encryption technology to protect Personal Information, and firewalls to help prevent external access into our network. However, keep in mind that, despite our best efforts, data transmission over the Internet and data storage can never be 100% secure.

If our Website links to or integrates with third party websites, services, or apps, we will not be responsible for their data privacy and security practices or policies. Please review their privacy and security policies if you want to know how such third parties use and protect your information.

Accessing/Updating/Deleting Your Personal Information

If you would like to delete, update, or access the Personal Information we have collected from you, and/or deactivate or delete your Pinnacle 21 account, you can send an email to privacy@pinnacle21.com. Once we have verified your request, we will make reasonable efforts to comply with it, unless we have a legitimate interest in retaining your Personal Information as permissible under applicable law. If we do retain your information pursuant to a legitimate interest of Pinnacle 21, we will only continue to use your information in furtherance of this legitimate interest. We also reserve the right to limit or decline repeated, abusive, harassing, or otherwise unreasonable requests.

Questions?

Questions? Comments? Suggestions? We want to hear from you!
Email: privacy@pinnacle21.com
Phone: +1 (888) 507-2270
Mail: Pinnacle 21 LLC, 1777 Sentry Parkway W, VEVA 17, Suite 405, Blue Bell, PA 19422, USA

Information for European Union Individuals

If you or your business or employer is located in any country in the European Economic Area or in Switzerland (collectively, the "EU"), in addition to our Website Privacy Policy and Community Privacy Policy, the following information will also apply to the collection, storage, use, and disclosure of your information.

Our collection of information from EU individuals may be subject to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (the "GDPR").

If you are using our software or services on behalf of your employer, your employer is the controller of your personal information, and we are the processor. However, if you are using our software or services on your own behalf, i.e. as a private individual, then we may be the controller of your information. If you are using Community, then we are also a controller of your information for purposes of communicating with you regarding our other products. In either case, our contact information is:

Pinnacle 21 LLC
1777 Sentry Parkway West
VEVA 17, Suite 405
Blue Bell, PA 19422
Email: privacy@pinnacle21.com

Consent

By using our services, you acknowledge that your Personal Information is being processed pursuant to the following lawful bases: your consent, our and our customers’ legitimate interests, to fulfill requests made by you, and in order to comply with applicable law. You also consent to the processing of your Personal Information as described in our Website Privacy Policy and Community Privacy Policy, including to the transfer, use, and storage of your Personal Information to and in the United States ("US").

The data protection laws of the US (and other relevant countries) might not be as comprehensive as those in your country. You may withdraw your consent at any time by following the instructions in the “Your Rights Regarding Your Personal Information” section below, but this will not affect the lawfulness of processing based on consent before your withdrawal. If you withdraw your consent or decline to provide Personal Information to us, you may be unable to use our Services.

You also have the right to file a complaint relating to the processing of Personal Information with a supervisory authority.

Your Rights Regarding Your Personal Information

Since your Personal Information is subject to the GDPR, you have certain rights, including the right to instruct us to delete your Personal Information, or to restrict or object to the processing of your Personal Information. You can send us an e-mail to privacy@pinnacle21.com for more information on how to exercise those rights.

Privacy Shield Notice

We are a participant in the European Union – United States Privacy Shield, and Swiss – United States Privacy Shields (collectively, the "Privacy Shields").

Pinnacle 21 LLC complies with the EU-US Privacy Shield Framework and Swiss-US Privacy Shield Framework as set forth by the US Department of Commerce regarding the collection, use, and retention of Personal Information transferred from the EU, the United Kingdom, and Switzerland to the US. Pinnacle 21 LLC has certified to the Department of Commerce that it adheres to the Privacy Shield Principles. If there is any conflict between our Website Privacy Policy and Community Privacy Policy, and the Privacy Shield Principles, the Privacy Shield Principles will govern. To learn more about the Privacy Shield program, and to view our certification, please visit https://www.privacyshield.gov.

The types of data we are collecting under the Privacy Shields, the purposes for which each such type of data is collected and used, and the types of third parties to which we may disclose such data (and the purposes of such disclosure), are fully explained in our Website Privacy Policy and Community Privacy Policy.

You have rights, as set forth in our Website Privacy Policy and Community Privacy Policy, to access, edit, and have deleted your Personal Information. The choices and means offered to you for limiting our use and disclosure of your Personal Information are set forth in our Website Privacy Policy and Community Privacy Policy.

Notwithstanding any language to the contrary in our Website Privacy Policy and Community Privacy Policy, in any situation where we transfer Personal Information of EU individuals that we received pursuant to the Privacy Shields to third parties, we are potentially liable, and we have a duty to ensure that those third parties protect the Personal Information with at least the same level of security as is required by the Privacy Shields.

In compliance with the Privacy Shield Principles, we commit to work to resolve complaints about your privacy and our collection or use of your Personal Information. EU individuals with inquiries or complaints regarding our Website Privacy Policy and Community Privacy Policy should contact us at:

Pinnacle 21 LLC
1777 Sentry Parkway West
VEVA 17, Suite 405
Blue Bell, PA 19422
Email: privacy@pinnacle21.com

We have further committed to refer unresolved privacy complaints under the Privacy Shield Principles to the American Arbitration Association, a non-profit alternative dispute resolution provider located in the US. If you do not receive a response to your complaint from us within forty-five (45) days, or if your complaint is not satisfactorily addressed, please visit https://go.adr.org/privacyshield.html for more information, and to file a complaint. Please note that if your complaint is not resolved through the above-mentioned channels, you may have the right, under certain limited circumstances, to invoke binding arbitration before the Privacy Shield Panel to be created by the US Department of Commerce and the European Commission.

We are subject to the investigatory and enforcement powers of the US Federal Trade Commission with respect to our compliance with the Privacy Shields.

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