Case Studies
Implementation of Zinc MAPS is proven to generate a range of commercial benefits to our clients. These benefits range from improvements in compliance, to efficiency enhancements and direct cost savings.
Although the actual improvements within any given project will depend on the particular baseline process being used prior to Zinc MAPS implementation, the sections below summarise some of the benefits experienced by our clients across a range of parameters.
Compliance Benefits
In an increasingly regulated and competitive pharmaceutical industry, the need to guarantee a high level of compliance with both internal and external regulations is paramount to every pharmaceutical company.
Zinc MAPS can enhance compliance with approval procedures through transforming the transparency of the process, whilst increasing the accountability of individuals within it.
Case Study
Client A had experienced a number of complaints from industry members regarding materials produced and activities undertaken. The company was in the process of drawing up more robust and regulated operating procedures to ensure that future materials and activities fell within the relevant local guidelines.
As part of this process it became apparent that a number of different methods and approaches to copy approval were being used across the company and it was decided that a single, universal process would be beneficial.
Key priorities for Client A were visibility, transparency and, above all, accountability. A system was required which allowed clear overview of the entire copy approval process to promote and ensure consistency across the portfolio.
Client A contacted Zinc Ahead Ltd and was fully satisfied that Zinc MAPS fulfilled all of their defined requirements as well as providing a range of other highly beneficial features. Implementation of Zinc MAPS was rapid, with the application being rolled out across 200 users within a two month period.
Following implementation of Zinc MAPS, Client A saw the following results:
- Approval time was halved within six months.
- All brand teams operate under one SOP, regulated by the Zinc MAPS system.
- A team was assigned to monitor and randomly audit the quality of materials entering and leaving the Zinc MAPS system. Before Zinc MAPS, this type of analysis would have been extremely difficult, if not impossible.
- All approved materials are now stored in one place, with access restricted where appropriate.
- Staff benefited from a greater understanding of the copy approval process, thanks to the clarity of the Zinc MAPS system.
- Hard copy job bag storage was reduced, with only the certificate and final item now being stored physically.
Time–Saving Benefits
The pharmaceutical industry is renowned for employing staff of an extremely high calibre, and those team members contributing to the approval of promotional materials are no exception.
Due to the nature of the material being approved, and the potential consequences for litigation and corporate reputation if inaccurate material is distributed to customers, reviewers of promotional items are some of the most experienced, and well qualified within the company.
It is therefore critical that these individuals conduct review in the most efficient way possible in order to allow them to contribute their expertise to other areas of the business.
Human Resource costs have been demonstrated to be a highly significant component of the overall cost associated with paper-based approval.
Research conducted amongst 31 UK pharmaceutical companies indicates that approval stakeholders spend up to 30% of their time on job-bag review. Many stakeholders spend large amounts of time on simple clerical tasks, such as tracking job bags, which can be easily automated.
Case Study
Assessment of a small–medium affiliate (Client B) in which 30 individuals are involved in the review process revealed that the annual cost of review time was approximately £150,000.
Through a combination of highly transparent “Route Maps”, the ability to review remotely and excellent visibility of other reviewers’ comments, Zinc MAPS generates dramatic time–savings for key approval stakeholders.
Implementation of Zinc MAPS demonstrated this time saving to equate to 25% of baseline. In Client B, a company of 30 approval stakeholders, this represented an annual saving of approximately £40,000.
Capacity Benefits
Zinc MAPS presents information on materials moving through the approval process in a clear, logical way. This has a dramatic impact on the ability for approval teams to efficiently process a greater volume of material for approval within a finite HR resource.
Case Study
Client C implemented Zinc MAPS during late 2003 and by 2004 had 91 users actively using the application. During the first full year of approval activity with Zinc MAPS, the client had approved 1200 pieces of material.
Over the subsequent five years, a series of outstanding product launches resulted in expansion of the company and subsequent increase in the number of employees using Zinc MAPS. By 2008, 125 users were accessing Zinc MAPS, representing a 37% increase in the size of the user group compared to 2004.
However, during this same period, the number of materials approved rose by around 150% to almost 3000. In effect, each team member was able to process almost double the number of materials in 2008 compared to 2004.
Accelerated Approval Lead–Time
Research indicates that an average job bag takes between three and six weeks to reach completion. In an increasingly competitive Pharmaceutical Industry, approval processes can often be too slow to allow a rapid response to competitive threats. Reasons for delays in approval lead–time include:
- Reviewers being out of the office.
- Items being held by reviewers who are unable to review them due to other workload pressures.
- Items going missing during the approval process due to tracking problems.
As a web–based application, Zinc MAPS enables reviewers to access it from any location or review off–line if necessary. The application also facilitates a variety of workflow modes including “Open Access Review” which enables reviewer to “check out” material for review on a first–come, first–served basis. Open Access removes the issue of a single team member blocking review by other team members and helps to dramatically accelerate approval lead–times. Perhaps most importantly, the high level of transparency generated by Zinc MAPS ensures that items are never misplaced, while encouraging team members to complete their review efficiently.
Case Study
Zinc Ahead Ltd analyses performance improvements versus baseline during each Zinc MAPS implementations.
The chart below summarises the results for the pooled analysis of recent implementations in seven pharmaceutical companies generated during the initial three–month launch phase of Zinc MAPS. In summary, Zinc MAPS demonstrates a highly significant (p<0.0001) reduction in approval lead-time of 57%.
Qualitative Performance Improvements
Clients frequently report baseline approval processes to be frustrating and stressful parts of their job.
Because Zinc MAPS has been designed specifically for the pharmaceutical industry, all of the functions within the application have been optimised for this sector and developed to be as simple and intuitive as possible.
Case Study
Qualitative data from respondents in the same 7 implementations outlined in this section illustrate the high level of perceived benefit Zinc MAPS brings to the approval process company to traditional routes of approval. The diagram below shows the universal preference for Zinc MAPS expressed by users across seven key attributes.
Direct Cost Savings
As well as the potential for significant reductions in the time expended by valuable team members on the review process, traditional paper–based approval processes are associated with a high level of direct costs.
These direct costs cover expenses such as print, courier / postage costs, archiving and other consumables. Analysis on baseline approval processes often identifies these costs as being very significant, as the case study below illustrates.
Case Study
Client D was a operating a paper–based approval process to circulate materials for affiliate approval. In total, 90 employees were involved in the approval process.
Client D embarked on a competitive tender process in which Zinc Ahead Ltd was asked to participate alongside vendors of non-sector specific document management systems. Zinc MAPS was rapidly identified as the preferred solution due to the excellent fit it provided with the client’s requirements and Zinc Ahead Ltd was requested to implement Zinc MAPS as a replacement for the incumbent process.
Prior to implementation, an assessment of the direct costs of running the paper–based approval process was undertaken, which showed that it was costing the company approximately £200,000 per year. These costs were associated with the following activities:
| Cost Category | Approximate Annual Costs (£) |
|---|---|
| General Consumables (Paper etc…) | £5,000 |
| Couriers / Post / Fax | £100,000 |
| Draft Artwork Print | £90,000 |
| Archiving | £5,000 |
Six months on from implementation, Client D conducted a re–evaluation of direct costs of the approval process. Their analysis revealed that 70% of the direct costs identified prior to Zinc MAPS implementation had been removed, making the total implementation cost–saving in year one.
Over the course of three years, client D projected a total saving of £300,000 versus baseline.
Competitiveness Improvements
Zinc Ahead Ltd has been implementing Zinc MAPS projects since 2001. As the business cases outlined in the preceding sections illustrate, clients gain a wide range of benefits as a result of these implementations. Although these benefits are diverse, they can be summed up in a single word: “Competitiveness”. In certain circumstances, these overall competitiveness benefits are very tangible, as summarised in the case study below:
Case Study
Client E had a highly successful product in an extremely competitive therapy area. Important new data was being presented at an international medical conference on a different continent. Key members of the extended brand team were attending the meeting, while members of the approval team remained in the office. The data had been embargoed prior to presentation meaning that, although the client was able to undertake some preparatory work, final press materials couldn’t be prepared until the data was known.
The new data was presented over a weekend and showed an overwhelming benefit for Client E’s product. Within the space of a few hours, the client was able to create and approve all of the relevant press material as well as sales–force briefings.
Due to the web–based nature of Zinc MAPS, the approval team had been able to work effectively, in some cases from home, over a weekend to ensure that all of the necessary communication materials were produced and delivered in the shortest timeframe possible. This enabled the client to ensure that the maximum possible competitive advantage was gained for their product.
The client commented that this simply would not have been possible without Zinc MAPS.
Pan–Regional Sharing
The architecture of Zinc MAPS has been developed to enable global pharmaceutical companies to comply effectively with local regulations in each affiliate, as well as driving synergies between affiliates and headquarters.
Clients use the country / regional architecture of Zinc MAPS in three basic ways, illustrated in the diagram above.
Scenario 1: Corporate to Affiliate Distribution
Template materials produced at corporate / regional Headquarters can be easily distributed to affiliates for approval to the requirements of local regulatory agencies. In addition, Zinc MAPS enables the approved reference package used in the corporate material to be quickly re-used in local items, saving time and improving quality of materials. Senior team members at the corporate level have the ability to see whether template materials have been adopted by each affiliate, helping to ensure consistency of message–delivery across a region.
Scenario 2: Shared Review
Zinc MAPS facilitates shared reviews across a corporate / affiliate team. This is particularly useful where international materials are going to be used by a local affiliate and must, therefore, comply with local regulations. In many cases, materials used in Symposia at international meetings require this type of review.
Scenario 3: Implementation of Best Practice
In a highly–globalised industry, it is frequently the case that materials created in an affiliate have applicability elsewhere. Zinc MAPS enables users at a corporate / regional level to create pan–regional materials based upon “Best Practice” in a single affiliate. This helps to ensure that every affiliate benefits from materials approved in a single country.
System Metrics
Traditional approval processes are notoriously difficult to generate metrics from. In many cases, even an analysis of the total volume of materials reviewed in a given period can be troublesome.
Zinc MAPS includes a range of reporting tools as standard including:
Standard Audit Report
This displays aggregated data for the approval process across a user–defined date range. In addition, reports can be filtered by country and by product where required.
The standard audit report includes information on:
- Number of materials raised, reviewed and archived within the audit period
- Materials raised by product / country
- Volume of review conducted by team member
- Average approval time by item category
- Number of items recalled for reapproval
Time to Approve Report
The Time to Approve Report provides detailed analysis of the time taken to approve each item within the audit period. Data is also aggregated to show the mean time to approve material by product, as well as a mean figure for all items within each country.
User Responsiveness Report
The User Responsiveness Report summarises the mean time taken for each team member to complete their comments on items reviewed within the audit period. This report is particularly helpful for identifying “log jams” within the process and has been used by a number of clients to create a business case for the provision of additional resources within a review team.
Many clients also use the User Responsiveness Report to set Key Performance Indicators (KPIs) for their approval teams.
These types of metrics would be impossible to generate with traditional approval processes.
Compliance Benefits
In an increasingly regulated and competitive pharmaceutical industry, the need to guarantee a high level of compliance with both internal and external regulations is paramount to every pharmaceutical company.
Zinc MAPS can enhance compliance with approval procedures through transforming the transparency of the process, whilst increasing the accountability of individuals within it.
Case Study
Client A had experienced a number of complaints from industry members regarding materials produced and activities undertaken. The company was in the process of drawing up more robust and regulated operating procedures to ensure that future materials and activities fell within the relevant local guidelines.
As part of this process it became apparent that a number of different methods and approaches to copy approval were being used across the company and it was decided that a single, universal process would be beneficial.
Key priorities for Client A were visibility, transparency and, above all, accountability. A system was required which allowed clear overview of the entire copy approval process to promote and ensure consistency across the portfolio.
Client A contacted Zinc Ahead Ltd and was fully satisfied that Zinc MAPS fulfilled all of their defined requirements as well as providing a range of other highly beneficial features. Implementation of Zinc MAPS was rapid, with the application being rolled out across 200 users within a two month period.
Following implementation of Zinc MAPS, Client A saw the following results:
- Approval time was halved within six months.
- All brand teams operate under one SOP, regulated by the Zinc MAPS system.
- A team was assigned to monitor and randomly audit the quality of materials entering and leaving the Zinc MAPS system. Before Zinc MAPS, this type of analysis would have been extremely difficult, if not impossible.
- All approved materials are now stored in one place, with access restricted where appropriate.
- Staff benefited from a greater understanding of the copy approval process, thanks to the clarity of the Zinc MAPS system.
- Hard copy job bag storage was reduced, with only the certificate and final item now being stored physically.
Time–Saving Benefits
The pharmaceutical industry is renowned for employing staff of an extremely high calibre, and those team members contributing to the approval of promotional materials are no exception.
Due to the nature of the material being approved, and the potential consequences for litigation and corporate reputation if inaccurate material is distributed to customers, reviewers of promotional items are some of the most experienced, and well qualified within the company.
It is therefore critical that these individuals conduct review in the most efficient way possible in order to allow them to contribute their expertise to other areas of the business.
Human Resource costs have been demonstrated to be a highly significant component of the overall cost associated with paper-based approval.
Research conducted amongst 31 UK pharmaceutical companies indicates that approval stakeholders spend up to 30% of their time on job-bag review. Many stakeholders spend large amounts of time on simple clerical tasks, such as tracking job bags, which can be easily automated.
Case Study
Assessment of a small–medium affiliate (Client B) in which 30 individuals are involved in the review process revealed that the annual cost of review time was approximately £150,000.
Through a combination of highly transparent “Route Maps”, the ability to review remotely and excellent visibility of other reviewers’ comments, Zinc MAPS generates dramatic time–savings for key approval stakeholders.
Implementation of Zinc MAPS demonstrated this time saving to equate to 25% of baseline. In Client B, a company of 30 approval stakeholders, this represented an annual saving of approximately £40,000.
Capacity Benefits
Zinc MAPS presents information on materials moving through the approval process in a clear, logical way. This has a dramatic impact on the ability for approval teams to efficiently process a greater volume of material for approval within a finite HR resource.
Case Study
Client C implemented Zinc MAPS during late 2003 and by 2004 had 91 users actively using the application. During the first full year of approval activity with Zinc MAPS, the client had approved 1200 pieces of material.
Over the subsequent five years, a series of outstanding product launches resulted in expansion of the company and subsequent increase in the number of employees using Zinc MAPS. By 2008, 125 users were accessing Zinc MAPS, representing a 37% increase in the size of the user group compared to 2004.
However, during this same period, the number of materials approved rose by around 150% to almost 3000. In effect, each team member was able to process almost double the number of materials in 2008 compared to 2004.
Accelerated Approval Lead–Time
Research indicates that an average job bag takes between three and six weeks to reach completion. In an increasingly competitive Pharmaceutical Industry, approval processes can often be too slow to allow a rapid response to competitive threats. Reasons for delays in approval lead–time include:
- Reviewers being out of the office.
- Items being held by reviewers who are unable to review them due to other workload pressures.
- Items going missing during the approval process due to tracking problems.
As a web–based application, Zinc MAPS enables reviewers to access it from any location or review off–line if necessary. The application also facilitates a variety of workflow modes including “Open Access Review” which enables reviewer to “check out” material for review on a first–come, first–served basis. Open Access removes the issue of a single team member blocking review by other team members and helps to dramatically accelerate approval lead–times. Perhaps most importantly, the high level of transparency generated by Zinc MAPS ensures that items are never misplaced, while encouraging team members to complete their review efficiently.
Case Study
Zinc Ahead Ltd analyses performance improvements versus baseline during each Zinc MAPS implementations.
The chart below summarises the results for the pooled analysis of recent implementations in seven pharmaceutical companies generated during the initial three–month launch phase of Zinc MAPS. In summary, Zinc MAPS demonstrates a highly significant (p<0.0001) reduction in approval lead-time of 57%.
Qualitative Performance Improvements
Clients frequently report baseline approval processes to be frustrating and stressful parts of their job.
Because Zinc MAPS has been designed specifically for the pharmaceutical industry, all of the functions within the application have been optimised for this sector and developed to be as simple and intuitive as possible.
Case Study
Qualitative data from respondents in the same 7 implementations outlined in this section illustrate the high level of perceived benefit Zinc MAPS brings to the approval process company to traditional routes of approval. The diagram below shows the universal preference for Zinc MAPS expressed by users across seven key attributes.
Direct Cost Savings
As well as the potential for significant reductions in the time expended by valuable team members on the review process, traditional paper–based approval processes are associated with a high level of direct costs.
These direct costs cover expenses such as print, courier / postage costs, archiving and other consumables. Analysis on baseline approval processes often identifies these costs as being very significant, as the case study below illustrates.
Case Study
Client D was a operating a paper–based approval process to circulate materials for affiliate approval. In total, 90 employees were involved in the approval process.
Client D embarked on a competitive tender process in which Zinc Ahead Ltd was asked to participate alongside vendors of non-sector specific document management systems. Zinc MAPS was rapidly identified as the preferred solution due to the excellent fit it provided with the client’s requirements and Zinc Ahead Ltd was requested to implement Zinc MAPS as a replacement for the incumbent process.
Prior to implementation, an assessment of the direct costs of running the paper–based approval process was undertaken, which showed that it was costing the company approximately £200,000 per year. These costs were associated with the following activities:
| Cost Category | Approximate Annual Costs (£) |
|---|---|
| General Consumables (Paper etc…) | £5,000 |
| Couriers / Post / Fax | £100,000 |
| Draft Artwork Print | £90,000 |
| Archiving | £5,000 |
Six months on from implementation, Client D conducted a re–evaluation of direct costs of the approval process. Their analysis revealed that 70% of the direct costs identified prior to Zinc MAPS implementation had been removed, making the total implementation cost–saving in year one.
Over the course of three years, client D projected a total saving of £300,000 versus baseline.
Competitiveness Improvements
Zinc Ahead Ltd has been implementing Zinc MAPS projects since 2001. As the business cases outlined in the preceding sections illustrate, clients gain a wide range of benefits as a result of these implementations. Although these benefits are diverse, they can be summed up in a single word: “Competitiveness”. In certain circumstances, these overall competitiveness benefits are very tangible, as summarised in the case study below:
Case Study
Client E had a highly successful product in an extremely competitive therapy area. Important new data was being presented at an international medical conference on a different continent. Key members of the extended brand team were attending the meeting, while members of the approval team remained in the office. The data had been embargoed prior to presentation meaning that, although the client was able to undertake some preparatory work, final press materials couldn’t be prepared until the data was known.
The new data was presented over a weekend and showed an overwhelming benefit for Client E’s product. Within the space of a few hours, the client was able to create and approve all of the relevant press material as well as sales–force briefings.
Due to the web–based nature of Zinc MAPS, the approval team had been able to work effectively, in some cases from home, over a weekend to ensure that all of the necessary communication materials were produced and delivered in the shortest timeframe possible. This enabled the client to ensure that the maximum possible competitive advantage was gained for their product.
The client commented that this simply would not have been possible without Zinc MAPS.
Pan–Regional Sharing
The architecture of Zinc MAPS has been developed to enable global pharmaceutical companies to comply effectively with local regulations in each affiliate, as well as driving synergies between affiliates and headquarters.
Clients use the country / regional architecture of Zinc MAPS in three basic ways, illustrated in the diagram above.
Scenario 1: Corporate to Affiliate Distribution
Template materials produced at corporate / regional Headquarters can be easily distributed to affiliates for approval to the requirements of local regulatory agencies. In addition, Zinc MAPS enables the approved reference package used in the corporate material to be quickly re-used in local items, saving time and improving quality of materials. Senior team members at the corporate level have the ability to see whether template materials have been adopted by each affiliate, helping to ensure consistency of message–delivery across a region.
Scenario 2: Shared Review
Zinc MAPS facilitates shared reviews across a corporate / affiliate team. This is particularly useful where international materials are going to be used by a local affiliate and must, therefore, comply with local regulations. In many cases, materials used in Symposia at international meetings require this type of review.
Scenario 3: Implementation of Best Practice
In a highly–globalised industry, it is frequently the case that materials created in an affiliate have applicability elsewhere. Zinc MAPS enables users at a corporate / regional level to create pan–regional materials based upon “Best Practice” in a single affiliate. This helps to ensure that every affiliate benefits from materials approved in a single country.
System Metrics
Traditional approval processes are notoriously difficult to generate metrics from. In many cases, even an analysis of the total volume of materials reviewed in a given period can be troublesome.
Zinc MAPS includes a range of reporting tools as standard including:
Standard Audit Report
This displays aggregated data for the approval process across a user–defined date range. In addition, reports can be filtered by country and by product where required.
The standard audit report includes information on:
- Number of materials raised, reviewed and archived within the audit period
- Materials raised by product / country
- Volume of review conducted by team member
- Average approval time by item category
- Number of items recalled for reapproval
Time to Approve Report
The Time to Approve Report provides detailed analysis of the time taken to approve each item within the audit period. Data is also aggregated to show the mean time to approve material by product, as well as a mean figure for all items within each country.
User Responsiveness Report
The User Responsiveness Report summarises the mean time taken for each team member to complete their comments on items reviewed within the audit period. This report is particularly helpful for identifying “log jams” within the process and has been used by a number of clients to create a business case for the provision of additional resources within a review team.
Many clients also use the User Responsiveness Report to set Key Performance Indicators (KPIs) for their approval teams.
These types of metrics would be impossible to generate with traditional approval processes.