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Learn more about the IFAPP Academy/King’s College London, Medical Affairs in Medicines development, Certification Program

Presented by Dr. Gustavo Kesselring

Want to learn how to expand your skill set and continue your professional development in Medical Affairs?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

The IFAPP Academy welcomes Ana B. Salgado as the new Director of Strategic Planning

Ana B has extensive professional experience in Medical Affairs, Marketing, and senior Business Management. We look forward to her contributions to the sustained growth of the Academy and achieving our mission and goals.

Ana B. Salgado, IFAPP Academy Director of Strategic Planning

Dr. Ana B. Salgado is a highly motivated and energetic pharmaceutical business executive with extensive global experience.

A physician by training, after three years of practicing medicine in the emergency room setting, Dr. Salgado started her pharmaceutical career as Medical Affairs Manager in Roche- Colombia. Her high affinity for change and continuous learning took her career into marketing and the commercial business. She joined Pfizer, where she occupied positions of increasing responsibility in marketing at a country level (Colombia) and later, at regional (Latin America, Europe) and global levels. She worked on products and portfolios across several therapeutic categories including anti-infectives, anti-inflammatories, and neuroscience in collaboration with multi-disciplinary teams around the world. Dr. Salgado was responsible for the launch of Celebrex in Latin America, several neuroscience launches in Europe (Zeldox, Relpax, Lyrica) and she led the Global Team for Aricept (in an alliance collaboration with Eisai – Japan).

Expanding her knowledge into the commercial business, Dr. Salgado served in business operations roles at regional and global level. She became the Chief of Staff for the Established Products/ Emerging Markets Business Unit at Pfizer, a business unit with a $25B yearly turnover. In these roles, Dr. Salgado led and participated in several large and complex corporate initiatives including the mergers of Pfizer with Warner Lambert, Pharmacia and Wyeth; several company reorganizations and the creation of the Established Products Business Unit. Before leaving Pfizer, Dr. Salgado led a global transformation to a customer centric – digitally enabled marketing model.

Dr. Salgado received her medical degree from Pontificia Universidad Javeriana in Colombia. She is currently pursuing a Certificate in Financial Planning.

IFAPP Academy Meeting in Budapest

Budapest 2018

In November 2018, the IFAPP Academy was invited by Sandor Kerpel-Fronius to hold the annual face-to-face Steering Committee meeting at the prestigious Semmelweis University in Budapest, Hungary.

Just a few of the Academy’s Board members and operational team

The IFAPP Academy Board Members, stakeholders, IFAPP’s secretariats, and the operations team gathered the first evening in Budapest to share a light dinner, a couple of drinks, and some good conversation.  

The first morning of meetings kicked off with Professor Sandor Kerpel-Fronius, faculty at the Semmelweis University, giving us a history of the University, insider tips to the city, and an overview of the meeting agenda. 

Professor Sandor Kerpel-Fronius inviting us inside the Semmelweis University for our first meeting.

The Academy was excited to welcome Tim Aldwinckle, UCB representative, to the meeting. He was able to provide some great perspective in several areas of the discussion.

After a full day of presentations, the team enjoyed an amazing dinner at Budapest’s Museum Restaurant.

The IFAPP Academy meeting attendees gather for dinner at the Museum Restaurant

Day 2 of the meeting – Gustavo Kesselring and Xavier Luria discussed the strategic collaborations that the IFAPP Academy will be fostering in 2019. Peter Stonier also presented the updated contract with King’s College London. The afternoon was concluded with coffee and the recording of video testimonials starring some of the key representatives of the Academy.

It was a great few days in Budapest and wonderful for the team to be able to spend some quality time together and workout the logistics for a successful 2019 and beyond!

Check out some more of the pictures from the Budapest Steering Committee Meeting:

ICPM 2018 presents the IFAPP Academy, Medical Affairs in Medicines Development, Program Graduates

News from IFAPP Academy

ICPM 2018 presents IFAPP Academy Graduates

What is ICPM?

The International Conference of Pharmaceutical Medicine (ICPM) is the largest event for the International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP).

ICPM is held every two or three years and is aimed to provide state of the art information in key areas for our discipline and profession. ICPM 2018 was held in Tokyo, September 27th – 29th, (www.icpm2018tokyo.com) in collaboration with the Japanese Association of Pharmaceutical Medicine (http://www.japhmed.org) and brought together around 400 representatives from the pharmaceutical, clinical research, and regulatory arenas from all over the world.


Gustavo Kesselring, MD International Affairs, IFAPP

“Attending the International Conference of Pharmaceutical Medicine (ICPM) is an outstanding opportunity to learn about the news trends in pharmaceutical medicine and medicines development, besides networking with world class faculty from academia, pharmaceutical companies, and government officials in a friendly environment.

Since 2006, in Seoul, I have attended all ICPMs. Being in Tokyo this year, attending the latest ICPM, I am still thrilled about how Pharmaceutical Medicine can motivate people from all parts of the world to get together and discuss the Future of Medicines Development. Hope you don´t miss the ICPMs in the coming years.”


Dr. Marcos O. Perez III receiving his CMD Certificate

Dr. Marcos O. Perez III receiving his CMD Certificate

From left to right: Drs. Gustavo Kesselring, Warachal Eileen Faison (with CMD Certificate), and Honorio Silva

From left to right: Drs. Gustavo Kesselring, Warachal Eileen Faison (with CMD Certificate), and Honorio Silva

Dr. Honorio Silva Introduces the Graduates from the IFAPP Academy Program

Students graduating from the Program were invited to attend ICPM 2018 in Tokyo. Although not all of the students were able to make the trip for the ceremony, Dr Honorio Silva honored each of them through a presentation that included their pictures, job titles, and affiliations.

The students that were able to attend the ceremony were provided free admittance into the conference and presented with their Certificate in Medicines Development (CMD) during the awards ceremony, held the first day of the conference.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course.

Click here for more information! Applications are now being accepted for the 2019 Cohort. Application deadline is Dec. 1st, 2018

Meet Dr. Sandra Bosold

News from IFAPP Academy


Get to know the students of the IFAPP Academy!

The IFAPP Academy is proud to highlight the achievements and successes of our current students and alumni.

We would like to introduce you to, Dr. Sandra Bosold, a current student of the IFAPP Academy/King’s College London, Medical Affairs in Medicines Development, Certification Program.

IFAPP Academy featured student: Dr. Sandra Bosold

What is your name and job title?

Dr. Sandra Bosold, Scientific Advisor PIH

What do you feel is your greatest achievement?

One daily achievement is to manage my job responsibilities and the activities and needs of my family. Due to the flexibility of my employer and the appropriate infrastructure, it is possible to balance both.

What is your favorite hobby and/or activity outside of your work?

Gardening and family.

What do you enjoy most about being a Medical Affairs Professional?

Working as a MAP you are at the interface between the medical/scientific world and the interests of a company. Scientific exchanges with HCPs, participation in conferences, and discussions with patients are at the center of our activities and make this job incredibly interesting.

What has been the most beneficial aspect of the IFAPP Academy Program?

Besides the well-structured and detailed lectures, the live webinars with the opportunity to discuss certain issues with top experts but also with the IFAPP colleagues are extremely valuable.

How has your view of the medical affairs profession altered and/or improved?

While going through the curriculum it became clear that Medical Affairs is at the center of all activities and cannot be underestimated. The discussions with KOLs, the insights into patients’ journeys, the scientific knowledge and the cooperation with academia are the foundation of our business.

Any additional comments that you would like to make about the Program?

I have greatly benefitted from the exchange with colleagues from all over the world. IFAPP’s program is a truly global one.

Thank you, Sandra! The Academy looks forward to seeing your many great achievements and contributions to the Medical Affairs arena.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Applications are now being accepted for the 2019 Cohort. Click here for more information. Application deadline is December 1st, 2018.

Get to know the students of the IFAPP Academy



News from IFAPP Academy


Get to know the students of the IFAPP Academy!

Meet Maribel Tribaldos, Medical Head Vaccines at Sanofi Pasteur Pacific and Caribbean

The IFAPP Academy is proud to provide continuing professional development to Medical Affairs Professionals worldwide. This month, we would like to introduce you to, Maribel Tribaldos, a current student of the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program.

IFAPP Academy Feature Student: Maribel Tribaldos

What is your name and job title? Maribel Tribaldos, Medical Head Vaccines Sanofi Pasteur Pacific and Caribbean

What do you feel is your greatest achievement? From the professional standpoint, my greatest achievement has been to rapidly progress in my career while maintaining a work and personal life balance.

What is your favorite hobby and/or activity outside of your work? Reading and spending time with my family

What do you enjoy most about being a Medical Affairs Professional? The need of constant training and the strategic thinking needed for each product.

What has been the most beneficial aspect of the IFAPP Academy Program? Acquiring a knowledge that is very valuable for the job but is not easily available in the standard trainings.

How has your view of the medical affairs profession altered and/or improved? My view of medical affairs has improved, from a narrow perspective of a simple job description to a position that plays a paramount role in the products life cycle.

Any additional comments that you would like to make about the Program? I encourage all medical affairs professionals to enroll in this wonderful journey that will enrich your knowledge and advance your career.

Thank you, Maribel! The Academy looks forward to your continued success in the medical affairs arena.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

Get to know the students of the IFAPP Academy!

News from IFAPP Academy


Get to know the students of the IFAPP Academy!

Meet Asmaa Salah Abdel Khalek, a Clinical Trial Evaluator and Auditor at the EDA, the Egyptian Drug Authority.

The IFAPP Academy is proud to provide continuing professional development to Medical Affairs Professionals worldwide. This month, we would like to introduce you to, Asmaa Salah Abdel Khalek, a current student of the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program.

Asmaa Salah Abdel Khalek, Clinical Trial Evaluator and Auditor, EDA

What is your name and job title?

I’m Asmaa Salah Abdel Khalek, Clinical Trial evaluator and auditor at the EDA, the Egyptian Drug Authority.

What do you feel is your greatest achievement?

My greatest achievement could be simplified in my dream to improve the clinical trial regulation in my country, to cope with the international guidelines.

Currently, I’m working in the national NRA and due to my continuous search and education in the clinical research field, I can see a lot of obvious gaps in the regulations of the clinical trials in my country. I truly hope to be one of the team that will standardize and unify the clinical trial regulations which will have a great impact on the provided pharmaceutical services across all the different healthcare sectors. You start to improve the moment you figure out the weak points and work on them.

What is your favorite hobby and/or activity outside of your work?

My favorite hobby is walking in an open area, listening to my favorite music.

What do you enjoy most about being a Medical Affairs Professional?

First, it was a great honor for me to hear about the medical affairs professional degree provided by IFAPP. I’m totally interested in this specialty which is now the direction of all the huge pharmaceutical companies.  Working in a patient-centered approach, integrating the medical affairs specialists as key members along the entire product lifecycle.  Through a mutual collaboration with all the company staff, starting from studying the market to detecting the medical needs, aiming to meet these needs, then helping the academic scientists to deliver their basic research and input, to shift from bench to lab, and then the huge massive clinical trial initiation, and monitoring, regulatory approval and marketing authorization, marketing plan starting from studying the market, targeting the main stakeholder, positioning etc.…. followed by the post-marketing and outcome research studies that may help to support the product value. Medical affairs is a broad concept, it could be an MSL, CRA, marketing team, regulatory affairs and so much more.

This is a new direction with a great impact, improving the performance. And for me, I’m completely interested in the clinical research sections and regulation pre and post-marketing authorization.

What has been the most beneficial aspect of the IFAPP Academy Program?

The most beneficial aspect of the IFAPP Academy Program is its professional organization which truly helped me to make a complete picture of the medical affairs profession.  Also, the lecturers, listening to these lectures from professional professors who already have a great experience and are completely updated in that field was very helpful. Lastly, the rich content and the flexibility of the program.

How has your view of the medical affairs profession altered and/or improved?

The medical affairs profession altered to be patient-centered and improved to make a great progress across all the product lifecycle, integrating with all other sectors in the company.

Any additional comments that you would like to make about the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program?

I would like to say thank you to all the IFAPP team and the program director for their patience and the great support they presented to us in this great program.

Thank you, Asmaa! The Academy looks forward to seeing your many great achievements and contributions to the Medical Affairs arena.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’

News from IFAPP Academy


The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’


Core Competencies of Medical Affairs

The IFAPP Academy/King’s College, Medical Affairs in Medicines Development, 2018 Cohort is finishing up Module 4 exams, starting this week. This means there are only 2 Modules remaining before the End of Program Assessment, to culminate in the Certification of this year’s qualifying students. Students successfully completing the program will be able to use the post-nominal letters CMD as a designation of their earned competencies.

The IFAPP Academy Core Competencies align with the McKinsey & Co report on the Core Capabilities of Medical Affairs Professionals.

MCKINSEY & CO CORE CAPABILITIES IN MEDICAL AFFAIRS
IFAPP STATEMENT OF COMPETENCE IN MEDICINES DEVELOPMENT
Scientific and technological leadership
and strategic vision
Can identify unmet therapeutic needs, evaluate the evidence for a new candidate for clinical development and design a Clinical Development Plan for a Target Product Profile.
Scientific and technological leadership
Can design, execute and evaluate exploratory and confirmatory clinical trials and prepare manuscripts or reports for publication and regulatory submissions.
Learning agility
Can interpret effectively the regulatory requirements for the clinical development of a new drug through the product life-cycle to ensure its appropriate therapeutic use and proper risk management.
Deep understanding of compliance
Can evaluate the choice, application, and analysis of post-authorization surveillance methods to meet the requirements of national/international agencies for proper information and risk minimization to patients and clinical trial subjects.
Strategic vision & scientific leadership
Can combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations within the organization.
Deep understanding of compliance
Can appraise the pharmaceutical business activities in the healthcare environment to ensure that they remain appropriate, ethical and legal to keep the welfare of patients and subjects at the forefront of decision making in the promotion of medicines and design of clinical trials.
Emotional intelligence and communication skills
Emotional intelligence and communication skills

According to McKinsey & Co. (Evers, et al., 2014), “the bar is high for Medical Affairs talent. They need to collaborate with R&D colleagues and deeply understand the science that underpins their work; they must understand the rules and regulations governing the industry almost as well as their compliance and legal department colleagues; and they should have the strategic thinking capabilities of their marketing counterparts as well as the customer-interaction skills of their colleagues in sales.”

IFAPP Academy students gain the necessary knowledge and understanding to create patient-centric environments where they can interact with a broad range of stakeholders to provide a more tangible value to patients. This has become increasingly important as “the right talent is often scarce, especially at the local country level.” The IFAPP Academy is proud to help fill this gap by providing online Continuing Professional Development for Medical Affairs Professionals.

For more information and to apply for the 2019 IFAPP Academy/King’s College, Medical Affairs in Medicines Development Certification Program click here.

References

Evers, M., Edd, F., Ghatak, A., Hartmann, J., Westra, A., Nathoo, A., . . . Suresh, B. (2014, July). Pharma Medical Affairs: 2020 and beyond. Retrieved July 18th, 2018, from McKinsey & Co.: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharma-medical-affairs-2020-and-beyond#0

Check out these 5 key areas for CRO process improvement

Hot Topics in Medical Affairs


5 Key Areas for CRO Process Improvement

Insight into 5 key areas where CRO’s should consider ongoing process improvement.


An article from the May 2018 addition of the Clinical Researcher seems especially relevant as the students of the current 2018 cohort are wrapping up Module 4, Clinical Trials: from concept to clinical study report. The article “Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations” (Ted Finlan, 2018), Finlan provides insight into 5 key areas where CRO’s should consider ongoing process improvement.



1.      Regulatory Compliance

Pitfall: Failure to understand and plan compliance timelines

Internal and external regulatory groups have varying deadlines, with timelines that often intersect and overlap. For instance, approval for a drug import license can vary from country to country by a matter of weeks or months. Without a clear understanding of approval processes and their impact on the critical path, a study is at high risk of schedule slippage.

Best practice: Clear project planning blueprint

CROs should ensure clarity and alignment between staff responsible for designing a regulatory blueprint (e.g., ethics committees, institutional review boards, etc.) and those responsible for building, managing, and communicating schedules. When approval processes are clearly mapped out to achieve the most efficient response, CROs can expedite the commencement of work.

2.      Information Flow and Governance

Pitfall: Lack of communication between departments and across organizations

Every department maintains critical information that other departments can benefit from. For instance, the Quality unit may be the first to become aware of new clinical trial regulations that impact the study start-up processes. If this information is not shared across the organization, various issues may arise, such as compromised core processes and missed timelines, jeopardizing overall delivery of the study.

This risk can be especially acute when working with new partners or third parties. Misplaced assumptions about “who knows what” or misaligned processes can creep in and drive quality issues or delays if initial and ongoing communication between these entities is lacking.

Best practice: Purposeful communication and collaboration

Clarity is a best practice when it comes to communication, and standard operating procedures should address optimal information flow. This requires every team member and site to have a clear understanding of their own responsibilities, as well as the roles and responsibilities of those adjacent to them. Processes should lend to proactive knowledge sharing as departments recognize how information intersects and how teams can fully leverage intelligence.

Mutually agreed-upon terms of engagement between sponsors, CROs, and vendors can also circumvent downstream quality, compliance, or timeline issues. These communication plans should ensure collaboration across all facets of the project.

3.      Getting a Fast Start

Pitfall: Final protocol delays

Delayed availability of the final protocol is one of the most significant stumbling blocks to patient recruitment. The final protocol is a critical path deliverable that impacts trial supply, site activation, and, of course, recruitment.

In fact, quite often, important work will begin before the final protocol is available. Proceeding “at risk” can lead to rework that can increase the cost and duration of start-up, and, in some cases, could lead to losing access to desirable clinical investigators or institutions. All of which impacts the ability to recruit and can affect the pace of recruitment throughout the study.

Best practice: Transparency and communication

Visibility into the availability of the protocol and expected impacts can significantly mitigate the impacts of delays. By actively planning for the delays and communicating proactively with the sites, a CRO can maintain engagement and be far more agile in adapting to change. This requires proactive communication and strong collaboration between the sponsor and CRO to make the changes needed for strategies, systems, and plans to run as smoothly and quickly as possible.

4.      Budgeting

Pitfall: Improper management of uncertainty

A key characteristic of research is uncertainty. Unfortunately, that reality can make the budgeting process a series of “best guesses.” As noted above, delays in protocol availability can delay studies for unpredictable periods of time, as can the availability of investigational product (IP) supplies.

These, and other unknowns can lead to rework, changing of staff, and other impacts that affect the overall budget, including direct CRO services, grants, and third-party costs. Without effectively forecasting communication and change order processes, studies can run into financial trouble, including an inability to compensate investigators or pay third-party costs.

Best practice: Effective change management

In an ideal world, any CRO would like to minimize risk by matching the level of uncertainty with the right amount of “insurance,” often referred to as a reserve. This is rarely possible, yet the most effective CROs move forward with a considered, deliberate approach for “out of scope” work and a smooth change order process.

Another approach is to financially ensure alignment and motivation through targeted use of bonus clauses, incenting CRO performance by aligning its financial benefit with the goals of the sponsor. For example, hitting aggressive recruitment and retention targets.

It is important to remember that these approaches are two-way streets. Change orders for unused/unrequired spending result in savings for the sponsor and should be communicated just as proactively. As this may be driven by faster recruiting or other “good news,” it may appear to some that the CRO is being punished for exceptional performance. This is another good reason to align incentives and bonuses to match the sponsor’s desired outcomes.

5.      Staff Workflows

Pitfall: Finding projects short-staffed

Inefficiency is always a concern, and the ability to efficiently allocate staff is a critical factor for service companies. A lack of consistency across organizations, various conflicting or ambiguous definitions for terms and data, misaligned assumptions, and an absence of clarity across processes and organizations can leave projects short of key staff, driving delays, quality issues, and other delivery problems.

Best practice: Aligning key resources

A holistic view of processes and clear data definition across the enterprise is key. This is usually attacked by mapping and integrating core processes, and in the case of services staffing, this is often referred to as the “quote to cash” process. As it sounds, this process takes the proposal and bidding activities into consideration, where staff capacity transitions to the reservation of specific individuals.

Once the formal assignment is in place and resources are used, the process moves into the billing and receivables portion. By clearly illustrating the processes and agreeing to common data definitions and metrics, the CRO can gain greater visibility into its “factory” and more efficiently serve its customers.

To sum up, “Good Business Operations = Effective Trials.”  Finlan, emphasizes that as the clinical research environment continues to grow and change it becomes ever important to ensure a high-quality design to overcome these common pitfalls and ensure success!

Want to learn more about how to be an effective and more productive CRO?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

 

References:

  1. Ted Finlan, P. C. (2018, May 15). Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations. Clinical Researcher, 32(5). Retrieved July 7, 2018, from https://www.acrpnet.org/2018/05/15/improving-clinical-research-trials-best-practice-dos-donts-managing-business-operations/