Clinical research organization business plan

In a person with food allergy, the immune system reacts abnormally to a component of a food—sometimes producing a life-threatening response. SinceNIAID has substantially increased its support for food allergy research, from basic research in allergy and immunology to epidemiological and observational studies to identify risk factors and to clinical trials that are testing new strategies to prevent and treat food allergy.

Clinical research organization business plan

As Catalyst co-founders and principals, Betsy Brown and Jean Hendrickson are industry leaders known for their transparency, integrity, and creative, out-of-the-box thinking and service delivery. Whether you need feet on the street or support in-house, we work with you to develop targeted, innovative and budget friendly solutions that address your unique business needs.

People like our outlook. Some call it refreshing. We call it customer-centric. In fact, our recent customer satisfaction survey results below speaks volumes of our commitment to quality and outstanding service delivery. Every program is unique. And even with the steep rise in clinical research labor, we will work with you to provide a high quality yet cost effective solution.

So with Catalyst as your partner, you receive the services, attention, and quality of a niche service provider all within a much friendlier budget. So whether you are a Sponsor, a CRO, or a Candidate, the last thing you need is a partner who is difficult to work with.

As a nimble, responsive organization, Catalyst strives to bring the utmost in flexibility to every situation, making your life a bit easier so that you can concentrate on more important matters, like bringing new products to those who need them most.

For exceptional levels of client service, standardized global procedures and ease of contracting, Catalyst is a proven and trusted choice for support of your international trials. Your organization is continually evolving, and we understand that every clinical program has a unique time and place that is often very different from the one it preceded or the one that may follow.

Whether a seasoned professional, a clinical monitoring team, or a full service solution is required, Catalyst comes through with deliberate strategies to ensure a successful outcome. What makes a difference in this industry is how organizations stand behind their work and their general integrity.

Jean Hendrickson and Betsy Brown have been hugely successful because of their integrity and commitment to their customers. No matter how big or small the project they act like they are your partner and that is why I would continue to choose them.

The monitors knew the protocol in detail, interacted with the site and CRO staff extremely well, closely and accurately monitored the sites, and contacted me as appropriate.

clinical research organization business plan

Their questions or concerns were appropriate and they discussed with me succinctly and in an articulate manner by writing and phone. I appreciated the fact that I was more free to function as a medical monitor and I could have confidence in the oversight of the sites.

It was literally the most enjoyable experience I have had in my 20 year pharmaceutical career, and I hope that I have the opportunity to work with such a group again.

The monitors Kim S and Maria G were knowledgeable, hardworking and well-liked by their sites. Ann Marie Cisneros is fantastic.

Flexible and great to work with! I have worked with many other CRAs and project managers placed by Catalyst, and they all are very seasoned, knowledgeable individuals with a team attitude. Just a few of many reasons summarized below.

Let us catapult your program to the next level. With more than two decades of experience supporting biotechnology, pharmaceutical and medical device companies, we understand the inherent challenges in operationalizing a clinical trial: That said, the last thing you need is a rigid outsourcing partner.

You need a partner who makes your work life easier and who contributes to the overall success of your program. You need an impetus, a driving force…well, a catalyst. And, we welcome you to interview and select each team member to ensure the right fit culturally as well as professionally.

Ideally, the chosen CRAs will be situated close to your study centers to save on travel time and expenses, and each team member will have the exact therapeutic and functional experience to contribute to your program from day one.

This model allows you to maintain control over your study and participating study centers, while being very kind to your budget. With the increase in outsourcing, regulatory authorities are cracking down on Sponsors for not providing the required oversight and governance to their outsourced projects.

Data integrity and patient safety: Each partner company is expert within their respective functions, bringing qualified, experienced resources and expertise to your programs, so you gain all the benefits of engaging quality, niche functional services, but all under one umbrella.

Depending on the level and complexity of Data Management and Biostatistical services required, we will recommend one of our like-minded partners.

Our data management and biostats partners offer an array of data services including both paper and EDC-based trials, including database design and build, as well as industry leading statistical analysis and reporting services.

For safety reporting and safety management we also partner with a niche providers depending on the study phase and complexity of the safety services required. With decades of experience working with pharmaceutical and contract research organizations handling all medical and safety aspects of clinical trials, across diverse therapeutic areas and trial designs, our safety partners are second to none.

Catalyst has a great deal of experience supporting sponsors in complete project rescue and transition planning. Catalyst can also take on a segment or function of the study from the current provider, which can often result in re-stabilizing the entire program and getting the trial back on track.

Remote Data Review Sometimes you have more data coming in than people to review it:Overview. Clinical trials are research studies conducted in people to determine whether treatments are safe and effective.

Without clinical research and the help of human volunteers, there can be no better treatments, no prevention and no cure for Alzheimer’s disease.

clinical research organization business plan

Syneos Health TM consulting practitioners span the entire product development and delivery continuum, adding high-value counsel and recommendations that make for more successful clinical development and brand launch is the only fully integrated biopharmaceutical solutions organization.

Our company, including a Contract . Grant award stimulating research at health professional academic institutions with not more than $6 million per year of NIH support in total costs in each of four or more of the last seven years.

NCI supports research to address cancer disparities among American Indian and Alaska Native populations. In this video, two researchers advocate for more culturally sensitive practices to help people who are most disproportionately affected by cancer disparities.

Since , NIAID has substantially increased its support for food allergy research, from basic research in allergy and immunology to epidemiological and observational studies to identify risk factors and to clinical trials that are testing new strategies to prevent and treat food allergy.

Sep 25,  · The PHS Research Plan form is used only for research, multi-project, and SBIR/STTR applications. This form includes fields to upload several attachments, including the Specific Aims and Research Strategy.

Contract Research Organization (CRO) | Clinical Research Organization