Welcome to 
TurboRegs is an essential regulatory document authoring,submission and review system created to support pharmaceutical/biotech companies and investigative sites.
TurboRegs is an essential regulatory document authoring,submission and review system created to support pharmaceutical/biotech companies and investigative sites.
The EU General Data Protection Regulation ("GDPR") came into force across the European Union on May 25, 2018 and brings with it the most significant changes to data protection law in two decades.
Based on privacy by design and taking a risk-based approach, the GDPR has been designed to meet the requirements of the digital age.
The 21st Century brings with it broader use of technology, new definitions of what constitutes personal data, and a vast increase in cross-border processing. The new Regulation aims to standardize data protection laws and processing across the EU; affording individuals stronger, more consistent rights to access and control their personal information.
TurboRegs™/Study Budget Pro™'s registered office is at 102 Christopher Columbus Dr., Apt 909, Jersey City, NJ 07302. We are registered on the Information Commissioner's Office Register; registration number ZA535069, and act as the data controller when processing your data. Our designated Data Protection Officer/Appointed Person is Swadesh Sharma, who can be contacted at dataprivacy@turboregs.com or dataprivacy@studybudgetpro.com .
TurboRegs™/Study Budget Pro™ (TR™/SBP™) is committed to ensuring the security and protection of the personal information that we process, and to provide a compliant and consistent approach to data protection.
We have always had a robust and effective data protection program in place which complies with existing law and abides by the data protection principles. However, we recognize our obligations to meet the demands of the GDPR and the UK Data Protection Act 2018. Our preparation and delivered objectives for GDPR compliance have been summarized in this statement and include the development and implementation of new data protection roles, SOPs, policies, procedures, controls and measures to ensure maximum and ongoing compliance.
TR™/SBP™ has a consistent level of data protection and security across our organization and has implemented the following GDPR SOPs and Processes:
Information Audit Process - company-wide information audit to identify and assess what personal information we hold, where it comes from, how and why it is processed and if and to whom it is disclosed.
Policies & Procedure SOPs - data protection policies and procedures to meet the requirements and standards of the GDPR and any relevant data protection laws, including: -
Data Protection - our main policy and procedure SOP for data protection has been overhauled to meet the standards and requirements of the GDPR. Accountability and governance measures are in place to ensure that we understand and adequately disseminate and evidence our obligations and responsibilities; with a dedicated focus on privacy by design and the rights of individuals.
Data Retention & Erasure - we have an updated retention SOP and schedule to ensure that we meet the 'data minimization' and 'storage limitation' principles and that personal information is stored, archived and destroyed compliantly and ethically. We have dedicated erasure procedures in place to meet the new 'Right to Erasure' obligation and are aware of when this and other data subject's rights apply; along with any exemptions, response timeframes and notification responsibilities.
Data Breaches - our data breach procedures SOP ensure that we have safeguards and measures in place to identify, assess, investigate and report any personal data breach within 72 hours. Our procedures are robust and have been disseminated to all employees, making them aware of the reporting lines and steps to follow.
International Data Transfers & Third-Party Disclosures - Currently not applicable, however, where TR™/SBP™ stores or transfers personal information outside the EU, we will have robust procedures and safeguarding measures in place to secure, encrypt and maintain the integrity of the data. Our SOP include a continual review of the countries with sufficient adequacy decisions, as well as provisions for binding corporate rules; standard data protection clauses or approved codes of conduct for those countries without. We carry out strict due diligence checks with all recipients of personal data to assess and verify that they have appropriate safeguards in place to protect the information, ensure enforceable data subject rights and have effective legal remedies for data subjects where applicable.
Subject Access Request (SAR) - TR™/SBP™ does not capture, store or process any patient level data.
Legal Basis for Processing - all processing activities are reviewed to identify the legal basis for processing and ensuring that each basis is appropriate for the activity it relates to. Where applicable, we also maintain records of our processing activities, ensuring that our obligations under Article 30 of the GDPR and Schedule 1 of the Data Protection Bill are met.
Privacy Notice/Policy - our Privacy Notice(s) to comply with the GDPR, ensuring that all individuals whose personal information we process have been informed of why we need it, how it is used, what their rights are, who the information is disclosed to and what safeguarding measures are in place to protect their information.
Obtaining Consent - our consent mechanisms for obtaining personal data, ensuring that individuals understand what they are providing, why and how we use it and giving clear, defined ways to consent to us processing their information. We have developed stringent processes for recording consent, making sure that we can evidence an affirmative opt-in, along with time and date records; and an easy to see and access way to withdraw consent at any time.
Data Protection Impact Assessments (DPIA) - where we process personal information that is considered high risk, we have developed stringent procedures and assessment templates for carrying out impact assessments that comply fully with the GDPR’s Article 35 requirements. We have implemented documentation processes that record each assessment, allow us to rate the risk posed by the processing activity and implement mitigating measures to reduce the risk posed to the data subject(s).
Processor Agreements - where we use any third-party to process personal information on our behalf (i.e. Payroll, Recruitment, hosting et cetera.), we have compliant Processor Agreements and due diligence procedures for ensuring that they (as well as we), meet and understand their/our GDPR obligations. These measures include initial and ongoing reviews of the service provided, the necessity of the processing activity, the technical and organizational measures in place and compliance with the GDPR.
In addition to the SOPs and procedures mentioned above that ensure individuals can enforce their data protection rights, we provide easy to access information via our website: PENDING LINK of an individual’s right to access any personal information that TR™/SBP™ processes about them and to request information about:
What personal data we hold about them
The purposes of the processing
The categories of personal data concerned
The recipients to whom the personal data has/will be disclosed
How long we intend to store your personal data for
If we did not collect the data directly from them, information about the source
The right to have incomplete or inaccurate data about them corrected or completed and the process for requesting this
The right to request erasure of personal data (where applicable) or to restrict processing in accordance with data protection laws, as well as to object to any direct marketing from us and to be informed about any automated decision-making that we use
The right to lodge a complaint or seek judicial remedy and who to contact in such instances
Information Security & Technical and Organizational Measures TR™/SBP™ takes the privacy and security of individuals and their personal information very seriously and take every reasonable measure and precaution to protect and secure the personal data that we process. We have robust information security policies and procedures in place to protect personal information from unauthorized access, alteration, disclosure or destruction and have several layers of security measures, including: - Encryption of DATA in transit and at rest, access controls, password policy, pseudonymization, 2-factor authentication
TR™/SBP™ have designated Swadesh Sharma as our DPO and have appointed a data privacy team to enforce compliance with the data protection regulation. The team is responsible for promoting awareness of the GDPR across the organization, enforcing compliance, identifying any gap areas and implementing the new policies, procedures and measures.
If you have any questions about our processes and procedures for GDPR, please contact Swadesh Sharma, swadesh@turboregs.com or dataprivacy@turboregs.com or dataprivacy@studybudgetpro.com .