The typical implementation process for Akero software
Discovery & Planning: Project leads and the Akero team meet to outline goals, gather requirements, and map current marketing/admissions workflows.
Platform Setup: Akero is configured for the organization, including account setup, permissions, branding, and preliminary data imports.
Integration: Bespoke integrations with CRMs (such as Salesforce, Slate, or Microsoft Dynamics) and other systems are established to enable seamless data flow across tools.
Customization: Campaign templates, forms, workflows, audience segments, and automation rules are tailored to the organization’s specific needs.
Training: Akero provides onboarding resources and live or remote training sessions to ensure user adoption and proficiency across teams.
Pilot & Validation: A pilot campaign is run to verify performance tracking, data mappings, and to address any process bottlenecks.
Akero can be customized to address specific business needs, particularly within its marketing automation and project management solutions. The platform offers multiple points of configurability and adaptability for diverse industries, especially for marketing, education, and clinical research contexts.
Custom Forms and Landing Pages: Akero allows users to create and tailor lead capture forms, landing pages, and email templates. These can be embedded and styled to match an organization’s branding and unique data collection requirements.
Workflow Automation: The platform features highly customizable automation workflows, supporting the automation of emails, campaign actions, data tagging, and more. Users can set conditional triggers, design multi-branch workflows, and automate nurture streams based on business logic needs.
AI-Driven Personalization: Akero employs dynamic content personalization and AI-driven segmentation, enabling organizations to create custom rules for how specific audiences experience campaigns, emails, and content.
API and Integrations: Akero exposes robust APIs, making it possible for developers to customize integrations and synchronize the platform with CRMs or other business platforms such as Salesforce, Microsoft Dynamics, Google Sheets, or via Zapier.
Custom Analytics and Reporting: The reporting tools are configurable, allowing users to build custom dashboards and tailor metrics to business and regulatory needs.
Audience Segmentation: Organizations can set up detailed custom fields and data mappings to optimize targeting and reporting.
Scientific and Clinical Guidance: Akero provides clinical development partners access to research protocols, scientific team input, and clinical documentation to support the precise execution of trials involving Efruxifermin (EFX).
Collaborative Engagement: The organization works closely with investigators during trial setup, including supplying protocol training, guidance on good clinical practice (GCP), and access to ongoing medical and technical support resources.
Regulatory and Compliance Support: Institutions and practitioners participating in Akero-sponsored trials receive administrative and regulatory training to comply with ethical standards and trial requirements.
Direct Contact and Responsive Assistance: Akero offers responsive contact channels via its corporate website for trial sites, clinicians, and research partners needing technical or scientific assistance.
Protocol Training: Detailed clinical protocol documents and statistical analysis plans are provided, which are core to onboarding new investigators and supporting trial operations.
Akero Therapeutics implements a range of security measures and privacy protocols to protect personal and health data, especially in connection with its clinical trials and research activities.
Data Handling and Access: Akero restricts access to personal data to authorized personnel and service providers for defined, lawful business purposes such as research, regulatory compliance, or technical support.
Use of Trusted Service Providers: Data is processed with the support of vetted service providers who supply cloud hosting, IT security, and management services, all of which are contractually obligated to meet high security standards and confidentiality requirements.
Compliance with Privacy Laws: Akero aligns its operations with data privacy regulations, such as GDPR for European citizens and U.S. health data privacy standards (HIPAA), and provides supplemental privacy notices for specific products or clinical programs to ensure transparency and legal compliance.
Strict Sharing Protocols: Data is only shared with healthcare providers, researchers, or third parties when necessary for medical, research, regulatory, or legal compliance purposes, and always under confidentiality provisions.
Incident Response and Legal Safeguards: Akero includes provisions for legal compliance in case of a breach, such as cooperating with authorities and notifying affected parties as required by law.
Transparency and Control: Individuals whose data is collected can request information on storage, demand corrections, or deletion, and opt out of non-essential data sharing or marketing.
Opt-Out Options: Users can choose to restrict certain uses of their information, such as analytics or marketing communications.
Clinical Trial Data Protections: For studies involving sensitive medical information, additional policies safeguard health data through administrative, technical, and physical security measures, and restrict data processing to specific study and regulatory purposes.
Akero Therapeutics’ policy on data ownership and portability is governed by its privacy practices, which outline collection, use, and control measures for personal information gathered through its website and related programs.
User-Provided Data: Individuals retain a degree of ownership over the personal and health information they provide. Akero collects this data for specific, disclosed purposes such as clinical research, recruitment, and website communications, while retaining the right to use it within those specified contexts.
Third-Party Access: Data may be shared with healthcare providers, researchers, service providers, and professional advisors solely for authorized operational, research, or compliance purposes. In these cases, Akero remains responsible for the privacy and handling of this data under its agreements and compliance standards.
No Explicit Commercial Resale: There is no evidence that Akero sells user data for commercial purposes; it may be transferred in the event of business transitions (merger, acquisition), as required by law, or to trusted partners bound by confidentiality.
Access, Correction, and Deletion Rights: Depending on governing law (e.g., GDPR), users may request access to, copies of, correction, or deletion of their personal data collected by Akero. These requests can be submitted by contacting the company’s privacy office.
Opt-Out Options: Users can opt out of certain types of data processing, such as marketing communications and behavioral tracking.
Akero Therapeutics' public-facing terms of use contain no specific provisions regarding the ability to scale up or down services to meet changing organizational needs. Instead, their website terms focus on general access and use, not on enterprise software subscriptions or scalable digital services.
No Stated Scaling Policies: There are no defined mechanisms for increasing or decreasing service levels, data volumes, user seats, or product features tied to organizational growth or contraction.
Discretionary Access and Changes: Akero reserves the right to change, suspend, or discontinue any part of the website or its content at any time, without prior notice or liability. However, this is not framed as a user-driven scale-up/scale-down capability—rather, it is a company right related to site management.
Service Adjustments: The company may, at its sole discretion, restrict, suspend, or terminate user access to all or part of the website at any time, again without specifying user-directed flexibility.
Akero Therapeutics' terms and conditions for contract renewal and cancellation, as articulated on its website, are broad and primarily focus on access to and use of the site and related materials, rather than on business software or subscription service contracts.
Unilateral Changes to Terms: Akero reserves the right to change the Terms of Use at any time without prior notice. Continued use of the website after revised terms are posted constitutes acceptance of those terms. There is no guarantee of prior notification for contract term modifications, placing the obligation on the user to review updates regularly.
No Explicit Renewal Clause: The Terms of Use do not define an explicit subscription or automatic renewal mechanism for digital services or licenses; ongoing access is governed by continued compliance with posted terms. Users are responsible for ceasing use if changes are not acceptable.
Company's Discretion to Terminate: Akero may restrict, suspend, or terminate user access—along with the agreement itself—at any time, for any reason, and without prior notice or liability.
No Refund Guarantees: There are no guarantees or specified provisions for refunds or residual value upon termination, as no subscription payment model is documented for website usage.
Survival of Key Provisions: Core sections such as limitation of liability, indemnification, and use of content clauses survive any termination or cancellation of the agreement.
User’s Right to Cancel: Users may effectively cancel their agreement by ceasing to access or use the website; acceptance of future terms is revoked by discontinuing use.
Akero Therapeutics meets rigorous compliance standards required for clinical-stage pharmaceutical companies, particularly within regulatory frameworks tied to drug development, data protection, and international clinical operations.
FDA Regulatory Compliance: Akero’s flagship program, Efruxifermin (EFX), is subject to strict compliance with U.S. Food and Drug Administration (FDA) clinical trial regulations, including Investigational New Drug (IND) and New Drug Application (NDA) requirements, as well as stringent data reporting and monitoring for each clinical phase.
EMA (European Medicines Agency) Standards: Efruxifermin (EFX) has received the EMA’s Priority Medicines (PRIME) designation, indicating compliance with EU clinical trial regulations and eligibility for expedited regulatory support in Europe.
Good Clinical Practice (GCP): All Akero-sponsored studies are conducted in accordance with GCP guidelines, covering sponsor, investigator, and protocol compliance, IRB/IEC review, informed consent, confidentiality, and retention of study records.
Institutional Review Board (IRB)/Ethics Committee (EC) Approval: All trials require IRB/IEC or equivalent ethics body oversight and documented consent, ensuring adherence to international standards for human subject protection.
GDPR (General Data Protection Regulation): For clinical research in the European Union, Akero is required to comply with the GDPR’s data protection requirements when handling EU residents’ personal and health data, including the assignment of Data Protection Officers and documentation of data processing impacts.
HIPAA (U.S. Health Insurance Portability and Accountability Act): Akero aligns data handling in the United States with HIPAA standards for health information privacy and security, especially in relation to protected health information (PHI) from trial participants.
