Information at your fingertips

Your information should not live in applications or vaults. You should not have to go search and find the information you need. Rather, the information should be readily available and brought to you – when you need it.

Having data that are consistent, reliable, accessible and well linked is still one of the biggest challenges facing pharmaceutical R&D today. Adopting an information-centric approach, with a focus on making the information available in each functional area and through the whole information life cycle, will greatly facilitate the ability to find, use and share data.

Surfacing not just the immediate information users are working with, but also all related and connected information, allows rapid and effective decision making by permitting users to deeply examine the data.

Read on to learn how AIMS provides you with a window onto the world of your information.

Getting Your Tasks Done

Everything you need to get things done in a single screen

Your information does not live in application or vault-defined siloes, but is seamlessly integrated across all business processes you work with.

When working on tasks a complete view into your information is presented with a tailored experience based on your individual perspective, making it easy to get your tasks done quickly and correctly.

Conversely, we don’t believe you have to go to a task list or inbox to complete your task if we are already working with a piece information. Just as we bring all information to a task, we also bring all tasks to your information.

One Stop Task List

Comprehensive task list provides all information and capabilities needed to perform tasks. Want to look at the older versions of a document you are reviewing? – Sure. Need to edit a timesheet sent to you for approval? – No problem.

Any part of your business process can be done directly in the task.

True Contextual Help

Our contextual help knows what you are doing right now. Unsure if a reaction is a medically important condition? – We’ll provide your own company’s guidance. Think a similar case may be a duplicate during a case book in? – We tell you how to make the determination.

We will even show you all applicable procedures and let you know if you are compliant with training.

Related Information

Sometimes you need to consult with related information before making a decision when completing a task. Need to look at product information related to an adverse event? – Right here.

We give you the complete picture so you can make informed decisions.

Features

Full Lifecycle and Workflow visibility
Policy driven assignment of tasks
Tasks can be assigned to individuals or groups
Policy driven delegation of tasks

Automatic delegation of tasks when out of office
Task due dates
Ability to snooze tasks
Assign task priorities

Contextual help with specific instruction for what you are doing now
Embedded approved procedures applicable to what you are doing
Embedded compliance to help you stay current with training curricula

Embedded Compliance

Always see approved procedures, complete training as you work

We bring your current policies and procedures to you – where you need them and when you need them.

By letting you see which procedures apply to the work you are doing right now we minimize the risk of being out of compliance because you didn’t remember what procedures apply. By always showing you the latest approved procedures we minimize the risk of being out of compliance because you are following an outdated procedure.

By clearly showing you whether you need to train on the applicable procedures we make sure you know that your training records are up date. And if you do need to train on a procedure? We let you read and acknowledge the procedures right here and right now, of course. No need to go to a different system to create and enter your training record.

Features

Applicable procedures specific to your current context
Current and effective procedures are always shown.

View procedures directly in the browser
Color coded summary of training compliance

Display procedure status such as effective dates, etc.
Complete Read and Acknowledge directly when viewing procedures

Impact Analysis

Find out where information is used and what impact changes will have

Making quick and efficient decisions many times requires comprehensive views of linked, related or underlying data rather than just the information itself.

By automatically creating and managing semantic relationships between related pieces of information and letting you browse and explore these links in a one of a kind Information Browser, we let you answer questions that have been difficult to answer in the past.

Need to know what eCTD applications and submissions a particular Investigator Brochure is part of, and to which agencies they have been submitted and when? Need to assess impact of an emerging contraindication for a marketed drug? These are insights that are current difficult and time consuming to answer. We help to accelerate finding robust answers to these questions.

To achieve this end-to-end visibility across different functions such as discovery, clinical development, medical affairs and labeling we bring a number of capabilities, including single sources of data and documents, the ability to establish cross-linkages between elements, robust data quality, workflow management, along with robust access controls to ensure that specific information elements are visible only to those who are authorized to see it.

Collaboration

Collaboration is key to bringing drugs to market faster

In recent years, pharma and biotech companies have begun to embrace a more collaborative way of working to help overcome some of the challenges the industry is facing. Expiring patents, rising costs of bringing a drug to market, availability of new technology, and tight regulatory environments are just some of the reasons why they are forming all manner of partnerships, even with competitors.

We enable this growing need for external collaboration by making it easy to securely share information, both within the organization and with external partners and stakeholders, so that you can bring your drugs to market faster and more efficiently.

External Partners

Collaboration with external partners is a growing trend in Pharma R&D, be it with CROs, clinical trial investigators, outside consultants, partner companies, etc.

Our system has been built from the ground up with external collaboration in mind. As a SaaS service there are no complex networking configuration needed to allow access to the system. Our policy based access control framework lets you have complete control over what information each external collaborator can see and interact with, and our product security ensures that your information stays secure no mater where your partners are located.

Information Access

Our system has a real-time user interface and does not limit access to information to one person at a time. We let you share work on an information object with others, at the same time.

An example might be an expedited drug safety case that needs to be processed and reported by end of the day. Several people can collaborate on entering the data, with one person entering information about the adverse reactions while another person enters information about the suspect and concomitant drugs. This can be a signification help where work on highly complex information is needed.

Real-time Coauthoring

Meaningful collaborative authoring and review of documents have long been an elusive goal in Document Management.

By utilizing the built-in support for real-time coauthoring in Microsoft Office we support this out of the box. To make this a seamless experience we do not require documents to be sent to a separate SharePoint or OneDrive site for this to be enabled, you can coauthor documents directly in our system.

Path to Meaningful Automation

The benefit of unified visibility across your information

As we start to develop intelligence based on these patterns, the system will start to suggest actions and behaviors. Perhaps a workflow is usually started and routed to a group of people when a certain type of information is uploaded to the system. We can pick up on these patterns and start the process of automating them. As confidence in these predictions grow, some may be completely automated.

Built-in Data Pipeline

Our solution is built ground-up around a data pipeline. We use this data pipeline to provide many of our unique features, such as the unparalleled information visibility across business processes, the real-time nature of our interface, and our unmatched performance.

But that is not all. Because we natively have a data pipeline at our core it is also much easier to integrate into your existing data pipelines and data lakes for mining and discovery of business insights.

Supervised System

We have an execution engine that knows and controls every action taken in the system, whether they are manual task approvals, automated workflow actions, or interactions with 3rd-party systems through our APIs. This affords us an unprecedented level of visibility to everything that takes place in the system and paves the way for recognizing patterns in actions and behaviors.

Our vision for this expands to the notion of a supervised system, where power users train the system by using it normally, and increasingly focus on edge cases that cannot easily be recognized.

Operational Optimization

Last but not least, operational aspects can be optimized to help maintain system health and optimal performance.

Are complex reports run at the end of each month? The system can detect patterns in when and how the system is queried and make sure that the data is quickly retrieved without impacting the system performance.

Product Security

Secure information in a secure cloud

We treat security as an integral part of our business and with SaaS offerings for large enterprise IT customers it is incredibly important to us for this to be an area of strength. We know that you trust us with very sensitive data, and we strive to protect your data with the utmost care.

Our focus on security cover a broad range of topics including product security, physical office security, employee screening, office network security, business continuity, disaster recovery, data security, secure IT policy, asset security and data center security in order to provide the best overall security for our customers.

Here we focus on product related security topics. These are broken into 3 primary categories of security: operations security, development security and application security.

Operational Security

Communication Security
We use TLS for all communication, including internal server-to-server communication.

Data Security
We encrypt data at rest, have a robust access control framework, use the principle of least privilege, and audit use of privileges.

Network Segmentation
We use private networks for each of our environment, requiring VPN connections to connect and manage.

Monitoring
We have detailed monitoring with alerts when unexpected events occur such as SSH connections from new IP addresses, high network throughput, high CPU, new processes running on servers, etc.

Automation
With scripted and reproducible deployments we have audited configuration of all servers.

Two Factor Authentication
We require our employees and contractors to use 2FA.

Separation of Roles
We have different roles for development, ops, monitoring, etc. If a single person has multiple roles, roles cannot be assumed simultaneously.

Development Security

Security Design Reviews
All changes go through a security design review.

Product Architecture
The product is architected with security as a key priority.

Encryption Primitives
We use industry defined standards when encrypting data.

Code Reviews
Code is reviewed by a separate person than the author.

Application Security Testing
We leverage Application Security Testing (AST) tools during development.

Testing Dependencies
We don’t just test vulnerabilities in our own code, we also check for vulnerabilities in all of our dependencies also.

Secret Management
We use a vault to store secrets when possible.

Continuous Threat Modeling
We continually identify and document our trust boundaries and threat models in our system.

Application Security

Password security
We securely manage passwords:
– Use Libsodium APIs to hash password (currently using the Argon2id function)
– Enforce password policies on password strength, expiration, reuse and reset
– Support n-factor login for all users, including Authenticator apps, Biometrics, etc.

API Tokens
API Tokens are treated with the same level of security as passwords.

IP Allow-listing
Restrict the users of an account to only be able to log in from specified IP addresses or ranges (useful for enterprises that require that their users be on a VPN to use any service).

Sessions
Sessions are short-lived and invalidated when an account is deleted or a password changed.

Client side
Only data that a user has access to is ever sent to the client.