The two company’s systems, processes and organizational cultures were vastly different. The migration entailed both very detailed, system knowledge and document mapping; and aggressive timeframes for synthesizing and systematizing core Submission Authoring Processes and Cultural Norms and Ways of working between a wide variety of leaders and stakeholder groups within the two companies, in order to make mission critical submission timelines.

The Actions:

1. Developed the Strategic Plan and $2 Million Business Case that assisted a global team of senior Regulatory Affairs and IT executives in each of the company’s three core regions (Japan, Europe and the US) to understand and effectively implement the organizational and operational changes required to help migrate the Oncology Company’s 200,000+ regulatory documents into Global Pharmaceutical Company’s Documentum based EDMS.

2. Develop a Stakeholder Engagement Plan that helped manage important working partnerships with PreClinical , CMC, Clinical and Pharmacovigilance groups of both companies.

3. Discovered and defined all core processes of both companies to facilitate common processes and ways of working.

4. Facilitated many working sessions with leaders of both company’s Technical Functions and groups to analyze, map, migrate and convert submission documents from external systems and repositories such as Argus, CTMS and custom built portals and tools to enable the technical migration.

5. Developed Strategic Change, Training and Communication Plans to prepare all affected stakeholders for the many changes initiated by the merger, acquisition and migration.

6. Facilitated and managed the organizational transformation.

7. Facilitated and managed Requirement Solicitation Session to create new data, meta data and information models and architectures and explored best-in-class ETL tools and practices to expedite the migration.

The Result:

1. Of the last 3 submission migrations that the Global Pharmaceutical Company managed, this migration moved all but 112 out of approximately 240,000 documents successfully in the exact locations in the EDMS that they were needed.

2. The Global Japanese Pharmaceutical Company was able to file its 4 or 5 Core Regulatory Submissions as planned, with The Oncology Company’s documents folded into Core Submission Structures and Processes without a single business disruption or significant Regulatory Authority questions.

3. Clinical Scientists and Regulatory Document Authors globally, from both organizations began collaborating in more effective ways than ever before, and begun using virtual documents as a new tool to flexibly structure regulatory submissions so they could be filed in multiple countries at once; a capability not available in either company before the migration.

4. Regulatory Authoring processes were streamlined and the regulatory document development time was reduced from an average of 90 days to an average of 30 days.

5. During the Organizational Phase of the Project, developers of the Training Programs learned and propagated more effective multimedia and multi-disciplined training programs.

6. Science and IT Leaders of of the Global Japanese Pharmaceutical Company modeled subsequent mergers and acquisitions on the Program Management Process and Methods used in this migration.

The Core Team spent 2 years selecting a next best alternative to their home grown system. The project intended to evaluate the Industry Leading Solution for one whole year before making an assertive decision as to whether to purchase the web-based Enterprise Solution.

Additionally, the Core Team of 20 Diverse business leaders did not relate to each other well or productively and could not agree on a strategy or leader for the project. The Project Team, for this mission critical project had gone through (and asked for the dismissal of) two former project Managers (Strong Point Strategy was the 3rd).

The Actions / Key Contributions:

1. Provided Business Architecture, Enterprise Technology, Team Building, Business Process and Leadership Expertise to assess the team strengths and weaknesses and to reinvigorate the team’s mission and goal.

2. Provided individual Core Team Members support and coaching and created a special “Voice of the Business” Blog to enable them to share their insights and feel supported in their efforts.

3. Aligned regularly with management to transfer knowledge and insights to the team that would allow them to better understand the Founder’s goals and mission (ex: acted as a core Liaison between the company’s leadership and the project Team) – they did not have productive communication and engagement habits previously.

4. Regularly sequestered the team to teach them interpersonal skills such as: setting goals, making decisions, clarifying expectations, active listening, negotiation, & conflict resolution.

5. Helped the Core Team to Define the Difference between Current State and Future State and to identify and quantify key gaps in the company’s core computing/operating systems and to derive the top 5 priorities for improving core business function automation.

6. Acted as the Primary Company Business Representative to the core Replacement Technology Vendor.

The Result:

1. Helped the company support, teach and strengthen a core team of business leaders (for an entire year while they still kept their “Day Jobs”) to evaluate the Industry Software and make a mission critical decision for the company.

2. Enhanced and upgraded the Project Teams Interpersonal and Leadership skills. Many of these leaders went on to career advancement opportunities within the Home Health Care Company.

3. Provided the guidance, tools, environment and safety for the Core and Extended Teams to innovate ways to capture business requirements, define, evaluate and document never before documented core processes.

4. Enhanced business leader’s skills in Process Design, Technology Analysis, Technology Requirements Analysis and Business Case Development.

5. Facilitated more effective and productive ways, means and tools for corporate communications at all levels.

6. Instituted key leader blogs, “day in the life” profiles, newsletter articles and Video Updates from key business leaders (as an example).

7. Concluded the company’s largest ever project on-time and under budget (never before done via a project ½ the size) (the company decided NOT to purchase the Selected Industry Solution).