Methodology

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.

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.

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

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. 

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

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.