Agile Project Development for Pharma, Biotech and Medical Devices

The Agile methodology has had a significant impact on the software development and implementation in the Pharmaceutical industry whether it is Scrum, SAFe, Kanban, Lean or any of the many other frameworks. Conventions such as Daily standup, Sprints, Release Train, Retrospective and Timeboxing are recognized within the business departments outside of IT development to a greater extent. The iterative process is recognized worldwide as a contrast to the traditional waterfall methodology with longer planning and execution phases.

While the Agile Manifesto is clear in its tenets it can be difficult to implement it due to regulatory and documentationrequirements and conventional thinking. Therefore, it is important to understand where benefits can be reaped with Agile by utilizing the positive characteristics from various frameworks. HERAX utilizes the Agile methodology in all types of projects where it adds value as it is incorporated into our Pharma Business Architecture.

Agile in Pharma works, both in digital transformation and operational evolution. It’s a testament to the power of the approach that it can succeed in such a heavily regulated and specialized industry.

Analysis and
vendor selection

Contract and Planning

Process and Configuration

System Setup

Test and
Validation

Roll-Out

Pharma Business Architecture®

Pharma Business Architecture Circle

The benefits of using HERAX are improved and sustainable operational processes, IT projects implemented on time and budget, with the right level of quality and compliance, using a life science specific agile project methodology named the Pharma Business Process Architecture.

HERAX focuses on assisting life science companies in defining a framework for decisions, implementing IT solutions and optimizing processes, while keeping attention on results and benefits.

By using our extensive best practice and IT implementation knowledge in our methodology, we help companies in the Life Science area to become more efficient and to get more value out of their clinical and operational IT budgets.

The agile methodology, now in version 4, is continuously updated based on the best practices being developed in new projects every day by HERAX consultants.   

Customer Success Stories

EDC Selection & Implementation

The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation on raw SDTM analysis files. The goal was achieved in 10 months, from initial idea to go-live, and reduced the time from LPLV to database lock to 2 weeks.

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Developing a complete process framework

The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they...

Read more

CTMS strategy, selection and implementation

The company needed to align the processes in all 4 divisions, and create a consolidated view of all trial planning and execution activities. Implementing best practice for RBM in order to save time for monitoring, giving the capability to run more trials with the same staff. Migration of old legacy systems, new processes...

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Clinical Portals strategy, selection and implementation

The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. Analysis and strategy were done in 3 months, and the first trial... 

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Midsized pharma client implemented eTMF within 9 months

Client wanted to spin out it’s drug discovery operations into a new company within a strict timeline. This included transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail

Read more

Statistical Computing Environment, MDR and new processes

The client was struggling with
local installations of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access...

Read more

EDC

EDC implemented with midsized pharma client

A leading global pharma company within allergy in Europe wanted to digitize its data collection processes in all trials. Current paper based process was cumbersome, required too many resources and prolonged the time necessary for database lock and access to the clinical results

EDC

Problem

The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation on raw SDTM analysis files. The goal was achieved in 10 months, from initial idea to go-live, and reduced the time from LPLV to database lock to 2 weeks.

Solution

With assistance from HERAX, a set of Use Cases and Requirements were created, in order to evaluate a series of EDC vendors. HERAX’ vendor selection approach ensures an objective evaluation of the vendors' functionality against the use cases, and with additional 6 parameters (e.g. Implementation plan, price, strategic fit to clinical processes and IT architecture). 3 vendors demonstrated and were scored, each showing how to set up and report from a representative study. Based on this one vendor was selected.

In parallel new processes were developed based on HERAX' process analysis approach and knowledge of best class clinical operations, and new SOPs were written. The new processes were aligned between data management (eCRF design and data cleaning) and biostatistics (data analysis), to ensure the output from EDC could be loaded directly into the CDMS and analyzed.

Managing the organizational impact to the organization was also handled by HERAX as part of the project, together with key clinical staff, ensuring everyone was aligned and trained in time for go-live of the new system.

The implementation from idea to first study designed after go-live, was 10 months.

Realized benefits

After the EDC implementation multiple benefits have been realized. Manual work handling papers has been replaced with work focused on the clinical data and supporting a fast enrollment of patients and data reporting.

  • Patient enrollment and follow-up with sites improved with 80%
  • Time from LPLV to database lock decreased to 3 weeks
  • More than 90% reduction in CRF errors due to automatic checking
  • Clinical data is received on a continuous basis, and approved daily
  • Monitoring effort on source data verification reduced with more than 80%
  • Data management and biostatistics have saved more than 80% of effort on handling and cleaning data, before getting ready for database closure
  • Paper handling and printing costs have naturally been eliminated
     

If you want to hear more implementing or optimizing the use of EDC, and improving the processes to achieve a full digitized set of processes in clinical operations, please contact us.

Herdis Stavnsgaard

Herdis Stavnsgaard

Project Director

Phone

+ 45 3049 9634

CTMS

CTMS strategy, selection and implementation with large client

A large global pharma company needed a CTMS strategy in order to digitize and optimize all processes for planning and running clinical trials. In addition to a new CTMS solution, migration of data and alignment of processes between 4 divisions needed to be implemented.

CTMS

Problem

The company needed to align the processes in all 4 divisions, and create a consolidated view of all trial planning and execution activities. Implementing best practices for Risk Based Monitoring (RBM) resulted in reduced time spent on monitoring activities, giving the capabilities to run more trials with the same staff. In addition, HERAX assisted with migration of old legacy systems, new processes and training. Analyses and strategy were created in 6 months, together with agreement for new processes. Vendor selection took 4 months, and implementation and migration was done (phased approach – 1 division at the time)) in less than a year.

Solution

HERAX created an overall strategy for digitizing clinical operations together with all 4 divisions in 3 months. Then new core processes were created based on best practice and OoO functionality from most CTMS vendors. Vendor selection was based on first an RfI with 8 participants, and then 4 RfP contestants. They demonstrated their proposed solution of the specific user journeys created as a part of the analysis phase for clinical operations specialists, and a preferred vendor was selected. Implementation of base system took 6 months, and a phased migration of all 4 divisions, as individual big bang migrations, took an additional 6 months. It was important not to overload the business with project tasks and training while running studies.

All clinical processes for study feasibility and planning, monitoring, study management, reporting, SAE reporting, product supply and study closure were redone, creating core processes. Training was created as eLearning for all CTMS areas.

Realized benefits

Using the new CTMS has lead to multiple benefits, enabling the Clinical organization to plan new studies faster, due to a complete overview of internal resources, and access to past performance of investigators. This enables feasibility and study startup timelines to be much shorter. Among the measurable benefits are;

  • Enrollment time improved with 15 – 20% due to improved investigator selection
  • RBM introduction has eliminated about 30- 50% of all monitoring visits depending on TA
  • Protocol deviation findings have decreased with 20% due to more focus on site issues
  • Automated status reporting on all trials
  • Integration to eTMF and master data for all studies
  • Support for system provisioning for other clinical systems (EDC, IVRS, eTMF)

If you want to hear more about strategy development, selecting and implementing CTMS, and improving the processes to achieve a full digitized set of processes in clinical operations, please contact us.

John Aggerholm

John Aggerholm

Project Director

Phone

+ 45 2231 5041

SOP3

Developing a complete process framework for Midsized client

Leading global healthcare company headquartered in Basel, leaders in the science and medicine of pulmonary arterial hypertension, affiliates in 30 countries covering all major pharmaceutical markets worldwide.

SOP3

Problem

The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they had grown into.

When HERAX was contacted by the client, the Clinical Development organization had a clear need for process alignment and optimization across departments and geography to ensure consistent processes, knowledge sharing and expertise preservation.

Solution

Through interviews and workshops, HERAX performed an in-depth analysis of both cross-functional and departmental processes all across Clinical Development. The new SOP framework was created from the analysis of the existing processes and quality documentation, eliminating redundant and overlapping processes and closing gaps arisen during the rapid company growth.

HERAX wrote the high-level SOPs and scopes for all SOPs in the new framework and linked them to associated quality documents, departments, roles and IT structure.

The deliverables covered in-depth process analysis for all departments in clinical development, a complete quality document framework including scope, dependencies, SOP governance procedure and the development of high-level SOPs.

Voice of the Customer

“I loved working with HERAX as their consultants were always professional and knowledgeable. Their involvement in the project was a considerable improvement over the way we used to do it… it is a great way to implement clinical software”

- Head of Clinical Operations

High-level Approach

Agile

 

Realized benefits

The client realized many benefits from the help provided by HERAX. Among the measurable benefits are; 

  • Complete and clear overview of SOPs, dependencies and associated roles

  • Organizational Change Management was a part of the project from the start leaving the business with a clear understanding of specific changes for each role and benefits (what’s in it for me)

  • Updated, structured and easy to follow SOPs and supportive documentation - increased effectiveness and better use of clinical resources

  • Enabling true global collaboration across R&D both across departments and geography

  • New processes were developed to standardize across systems and harmonize the interdisciplinary business processes from clinical to IT


If you want to hear more about the development of a SOP framework, increasing global collaboration and optimizing processes all across Clinical Development, then please contact us.

Herdis Stavnsgaard

Herdis Stavnsgaard

Project Director

Phone

+ 45 3049 9634

Portal

Clinical Portals, strategy, selection and implementation with large client (Pharma top 10)

Large global pharma needed portal strategy. First portal for clinical development for running studies for Clinical Operations, both operating studies and distribution of SUSARs to investigators. Second portal for investigators providing single point of access to EDC, IxRS, FileExhange, Labs and ePRO. Assistance included strategy, selection and implementation.

Portal

Problem

The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. Analysis and strategy were done in 3 months, and the first trial went live an additional 3 months later. 

There was a need for an external portal to support investigator's access to all systems with one login name and password, allowing deep linking, patient lab data access, and support of all investigator facing systems. Alignment with vendors and portal creation were done in 6 months, followed by a study based roll-out. 

Solution

HERAX created an overall portal strategy for clinical operation to support the operation of all combinations of studies, internal or stduies using CROs. New processes were created for quickly initializing a new study on the portal platform, and get started with study work. The platform enables easy team work between all study personnel working for the sponsor. To ease the safety communication with sites, a communication module with signature function was added to the solution. Despite being optional for ongoing studies to use, all studies decided to migrate to the solution. 

For the investigator portal, a staged approach was selected with the client. To support study staff, investigators and study coordinators, a simple portal, scalable to thousand of users, was chosen and initially configured for login support only. Second stage included adding functionality for communicating with investigators, showing combined information across systems and study metrics. 

Realized benefits

Using the new portals has provided benefits for both the pharma company and the site staff. Internally the flexibility supporting different combinations of study operations staff, has enabled processes and communication to function more effectively. For study staff, the investigator portal enables easy one-login access to all solutions needed by the site. Measurable benefits are; 

  • Document exchange time reduced with 50% (From email to portal) 
  • Login time reduced with 70% for all site staff 
  • Support for user login reduced with 70% 
  • Cost for safety information distribution reduced with 85% from courier mail to notifications with confirmation 
  • Onboarding and training of CRO staff reduced with 50% . Instant access to all study information and training modules 
  • Tracking of documents to/from sites, and for eTMF upload improved with 30% 
  • Feasibility document exchange tracking and workflow improved 
  • Communication with sites improved 
  • Less time used for approving patient lab data
     

If you want to hear more about how internal-, site- and patient portals can improve your study execution, please contacts us. 

John Aggerholm

John Aggerholm

Project Director

Phone

+ 45 2231 5041

eTMF2

Midsized pharma client implemented eTMF within 9 months

Leading European bio pharmaceutical company headquartered in Switzerland working with Fabry diseases and insomnia employing about 650+ people in 5 countries.

eTMF2

Problem

Client wanted to spin out it’s drug discovery operations into a new company within a strict timeline. This included transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail

Solution

With help from HERAX the client managed to select a vendor using HERAX vendor selection methodology which includes user requirement specification, capability demonstrations and negotiations to achieve best outcome from the selection.

After the vendor had been selected the chosen eTMF software was implemented with HERAX Pharma specific project management approach employing Agile methodology in collaboration with the vendor.

During the implementation change management were applied using best practices to ensure best adaptation to the new tool, processes and understanding of benefits for each role (what’s in it for me). New processes were developed to standardize across systems and harmonize the interdisciplinary business processes from clinical to IT. Standard operating procedures, work instructions and templates were updated/delivered to reflect the new system landscape.

Approach

  • Best practice, “out of the box” configurations to be used whenever possible
  • Workshops were a collaborative, iterative process  occurred in parallel with business process design work stream
  • Initial configurations were presented for feedback
  • Configuration changes were reviewed live in system enabling the end-users to see the impact of decisions directly in the system
  • Fit-for-purpose applied before final testing and go-live
eTMF

Realized benefits

Client managed transition within the given timeframe enabling efficient data capture, standardized compliance and inspection readiness from day one

If you want to hear more about how to select and implement eTMF solutions using an Agile methodology, please contacts us. 

Allan Bech Thomsen

Allan Bech Thomsen

Project Director

Phone

+ 45 3049 2100

SCE

High performing and scalable SCE implemented with
midsized pharma client

A global pharma company in Europe needed a SCE to support their growing Biometrics team. The new system should ensure global accessibility, simple versioning, audit trial and lean statistical programming processes.

SCE

Problem

The client was struggling with local installations of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access and audit trail was a challenge for ensuring inspection readiness.

Solution

HERAX helped the client select a vendor from a number of different SCE providers with the use of HERAX vendor selection methodology. The vendor selection included user requirement specification, use cases and negotiation with vendors to achieve the best outcome from the selection.

After selecting the vendor, the SCE solution was implemented with project management from HERAX utilizing our agile methodology together with Line of Business, IT and the vendor. The agile approach ensured quick delivery of critical functionality and alignment with the business processes.

New IT processes were developed to ensure efficient collaboration between the client’s IT department and the vendor. Statistical programming processes were created or updated to support a lean use of the new solution.

Demos and solution information were shared during the project as part of the Organizational Change Management and efficient training planning ensured a successful roll-out.

Voice of the Customer

“This implementation is an example of what fit for purpose is about. It was straight forward and smooth, the team knew what they needed and worked hard until the end”

- Head of Biometrics

Realized benefits

The solution was implemented in 6 months from idea to go-live. 

  • A centralized, cloud based SCE platform ensures global access to statistical programming tools and a single repository for clinical data

  • An efficient system design reduced the need for SAS server cores with 75%

  • Clear traceability to output programs used for regulatory submissions is established through version control.

  • Audit trail logs on access, programs and data provides documentation for inspections

  • Availability of widely used statistical programming tools and limited system restrictions ensures efficient processes and provides the ability to adjust and optimize the way of working.

If you want to hear more about SCE platforms, statistical programming tools and selecting the right SCE vendor, please contact us.

Jacob Jensen

Jacob Jensen

Senior Project Manager

Phone

+ 45 3049 2300