2
Nov

Global Clinical Research Market to Reach $60 Billion in 2020

Scientist looking through microscopeAccording to a newly released report by Zion Research, the global contract research market is expected to reach $59.42 billion in 2020. Last year’s market valuation was $34 billion. This accounts for a 10% compounded annual growth rate.
The demand for outsourcing clinical development to contract research organizations (CROs) has been rising steadily as a result of high in-house R&D cost as well as the high failure rate of clinical trials.
Another growing trend has been a rise in strategic alliances, joint ventures and acquisitions among vendors in the CRO market with the goal of expanding service offerings and global reach.
 
The report divides the CRO market into Americas, EMEA (Europe, Middle East and Africa) and APAC (Asia Pacific) regions with the US CRO market dominating half of the world market share in 2014. However, Asian, Latin American and Eastern European countries are popular research destinations as they provide access to large, low-cost patient populations as well as low-cost manufacturing and skilled clinical workforce.

According to the report, last-stage clinical development sector was the largest employer in the CRO market with more than 70% of the 2014 total market share. This includes phase phase II-IV clinical studies and central lab services. This sector is projected to have the fastest growth in the next five years.

Some of the major stakeholders in the CRO market are global contract research organizations such as Quintiles, Covance, Parexel, PRA International, Charles River Laboratories, Accenture and Cognizant.

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26
Oct

CROs and clinical research jobs can benefit from R&D tax credit

Tax reform has become an important issue in the 2016 U.S. presidential election. The U.S. Congress has also entertained the issue for a while. As a result, the Association for Clinical Research Organizations (ACRO) has focused on changes to the Research & Development tax credit that would help CROs and level the playing field between the U.S. and other countries. It has expressed its support of the COMPETE Act which, if passed, would expand the R&D tax credit to contract research organizations.

Right now, when a sponsor outsources clinical trial research and development, they can claim up to 65% of the eligible R&D expenses in tax credit. In the scenario of the research being conducted in house, they can claim 100%.

On the contrary, in Canada, the UK, Austria and France, CROs are eligible to claim the entire amount for the R&D credit because they are in fact the employers of all research staff. That is why ACRO is raising the point that while the U.S. will continue to be a hub for clinical research, a tax reform would help keep the U.S. competitive and encourage higher paid research jobs in the States.

Contract research organizations contribute to innovative medical product development and according to the sixth biennial Battelle and BIO report, research has been the fastest growing biotech sector.

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19
Oct

Silicon Valley BioTalks “eClinical Systems Integration” Takeaways


BioTalks
Clinovo recently hosted the 11th BioTalks on the topic of clinical systems integration at the HP Headquarters in Palo Alto. The panel featured clinical industry experts Carey Smoak (Portola Pharmaceuticals), Lin Wan (Stella Technologies) and Hajime Arnold (Wincere), and was moderated by Clinovo CTO Marc Desgrousilliers. The speakers shared their experience and views around challenges and best practices as well as the recent trends in the field.

One of the important takeaways was that not all systems integration is equal. For example, according to Hajime Arnold, there is much more value in clinical and safety data integration compared to CTMS and EDC due to the fact that safety data reconciliation can be a very costly and error-prone process which affects FDA submission, and can thus be streamlined with the right integrated solution.

Whether a company should integrate or handle using multiple systems depends on its maturity and internal processes in place. However, panelists pointed out that collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems, shows that the value of integrating is growing as users see the efficiency in storing and accessing data on a single interface.

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management of the product’s life cycle includes investigators, regulators and patients. This is where systems integration comes in, ensuring data is more accurate and consistent. If data were integrated from the start, it would be easily accessible at any point making the data review and cleaning process faster and with higher quality.

In response to the increase in demand, many new players have entered the market in recent years but according to Lin Wan, the industry still lacks innovation as there hasn’t been a breakthrough integration solution yet. In addition, more needs to  be done in terms of standardization and availability of open APIs. Panelists also observed the recent trend for real-time clinical integration in order to keep track of study progress. Another recent trend observed in larger clinical trials is the need for  integration between EDC, IVRS and central labs.

The challenges of integrating systems include ensuring validation, data security, resource availability and allocation, as well as communication between global teams. For example, panelist Carey Smoak and his former team at Roche Molecular,  were able to deliver real-time ad-hoc/monitoring reports using Enterprise Guide to create stored processes, run by non-SAS users using the SAS Add-in to Microsoft Office. They used the SAS Management Console to set up users, groups, roles and permissions. Once the proper users, groups, roles and permissions were created, then the process of creating and running stored processes was accomplished to monitor data in real-time. It took them 6-7 months to finish the project as validation, SAS components and the expertise required were very specific and not included in the traditional SAS programmer role.

In terms of best practices, all panelists agreed that before deciding on systems integration, a business should clearly define its objectives and project management workflow as project tracking is key in ensuring that resources are lined up and deadlines are met. Another crucial step is testing. Integrating systems drains a lot of time and resources so companies should always test and analyze the return on investment, then proceed with training and validation. The project team should also include all stakeholders- end users, PM, researchers and subject matter experts as well as business decision-makers.

Panelists explained that often times, small companies ask for EDC and CTMS integration when risk-based monitoring can be done without a system, on Excel spreadsheets. That is why it helps to work with vendors who understand the clinical trial process versus those that grew in the software world. Some vendors don’t have clinical trial industry expertise and their customers may end up having to implement processes around the system versus using the system to streamline the internal processes they already have in place. Researching the vendor’s customer case studies can be helpful in the decision-making process, for example. And as with everything else, communication is key in ensuring that all sides of the equation are aligned with the same vision.

 

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25
Sep

The Data Integration Challenge for CROs

Contract research organizations (CROs) always strive to enhance project oversight and decrease costs while adding value. As clinical trials are becoming more complex, multiple CRO partners often need to collaborate on a single project, and each CRO has its own portal and varying sets of reports, which means transferring information can be problematic. Even in the cases when the sponsor and CRO use the same CTMS, for example, APIs need to be set up for each trial. Simplifying data exchange is therefore crucial to fulfilling their trial-related duties.

Some find a workaround with CTMS by extracting data in spreadsheets, sending it to the sponsor and then importing it into their system manually. But they can run into problems such as inconsistent data requests or problems in mapping it to the sponsor’s back end data tables. Others use an SQL database or SharePoint for data entry, and skip CTMS altogether. That, however, presents many operational issues of providing consistent data extracts in the right format and manually managing their data.
Some sponsors also work with CROs on implementing CDISC clinical trial data models such as the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM). The CROs convert their studies into a common SDTM structure in support of eCTD and Integrated Summary of Safety analyses for a filing. Sometimes these studies were not done in-house which results in inconsistent eCRFs so the SDTM format benefits both internal data inspectors as well as the FDA. Using the SDTM structure has helped standardize the data structure (Treatment Names, Treatment Codes, Visit Names, Visit Numbers, MedDRA Encoding Version, and coding for Disposition Status). The table below further describes some materials that are helpful for the CRO to implement the SDTM conversion.

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Credit: Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables

To learn more about the new trends and solutions in eClinical systems integration, register for our next Silicon Valley BioTalks event happening on October 8th. Panelists would address questions such as: What are the key principles for a successful outcome? What are the new trends and players in place that are tackling the high cost of integrated solutions? Why are eClinical systems vendors and CROs instrumental in making progress and how can they accelerate this process?

11th Silicon Valley BioTalks
7
Oct

Key Takeaways from Outsourcing in Clinical Trials Conference

My colleague Joshua (Associate, Business Development) and I attended the Outsourcing in Clinical Trials (OCT) Conference in San Diego on September 24th and 25th, 2013. I have to say, the events put up by the Arena group are extremely valuable and the speakers are of excellent quality. These events are of particular interest to Clinovo, as they address the best practices for successful Sponsor/Contract Research Organization (CRO) collaboration. I don’t think anything I heard was new or revolutionary, as I believe that at Clinovo we always strive to follow the principles the speakers outlined, but it never hurts to reiterate them.

Here are some of my key take-aways:

  • Set up expectations that are mutually agreed upon by both parties: It is important to define expectations that both parties understand and agree on in order to avoid bad surprises down the road. I would add to this: define clear responsibilities. Your CRO needs to follow through and be held accountable for what they are responsible for.
  • As a Contract Research Organization (CRO), never promise what you can’t deliver. At Clinovo, we consider this a principle of particular importance. A successful relationship relies on trust, and that implies complete transparency on what one can deliver in what timeline. Before we give our milestone-based plan to our clients, we always check internally that the team is able to deliver what is outlined in the plan, and on time.  Additionally when a problem arises, a CRO must be transparent with the sponsor and discuss the issue with a proposed resolution.
  • Include all vendors at the kick off meeting. I had never thought about inviting all vendors to our kick off meetings, but it makes complete sense. Vendors are in pursuit of the same end-goal; delivering the highest quality to their customers, and contributing to bringing medical innovations faster to patients. Therefore, getting to know your counterparts and aligning goals is instrumental for a fruitful collaboration.
  • Plan the unexpected. You should always prepare a mitigation/risk plan. What happens if enrollment doesn’t start on time? Plans need to take into account what to do if things go wrong, and be detailed enough for anybody to take over if necessary.
  • Choose a CRO that is truly integrated to your team. Sponsors and CROs need to practice cooperative, strategic planning. As we all know, 1+1=3. Vendors are in the same boat as their clients, and will only deliver higher quality by truly understanding in depth their customers’ needs, processes, and values. Being fully integrated is key to a successful clinical trial.

I also wanted to share a great talk from SynteractHCR on how to select your optimum Electronic Data Capture (EDC) system. Below are 7 insightful recommendations:

  1. Develop high level requirements with all stakeholders – It’s hard to get everybody’s input, but try.
  2. Separate your requirements into must-have and nice-to-have.
  3. Avoid subjective requirements (e.g. nice GUI): It has to be something that is quantifiable that you can test.
  4. Determine which companies are likely to invest more in development and expend their EDC solutions.
  5. Look at your vendor’s system roadmap.
  6. Understand how the EDC system can integrate with other systems.
  7. Check reference accounts.

I want to add that, in the end, it all depends on your internal needs. There is no one magic solution or system out there that works for all sponsors. There are many considerations to take into account when choosing an EDC, including budget, resource capacity, the complexity and length of the clinical trial. So at the end of the day, it’s all about how your vendor integrates to your team and how your system is suited to your requirements.

Sophie McCallum
Director of Operations, Clinovo

 

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