We have seen people use the strategy to advocate for their children at school, participate in decisions that affect them at the welfare office, secure better job training opportunities, and partner more effectively with their healthcare providers.
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.
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: For any reason, allocating resources to ensure your study data is clean and appropriate early on can be a prudent investment in avoiding costly problems and surprises later.
Medical Writing With a broad and highly experienced network of medical writers, Catalyst can provide the specific expertise to support your IND preparation, safety narrative writing, clinical study report generation, manuscripts and NDA section writing.
Only pay for what you need. Over the years we have noticed that Sponsors often pay for services or functions from their provider that are already possessed internally. That can add up to a lot of savings. With the Catalyst CRO model, you receive the services, attention, and quality of niche providers all within a friendlier budget.
In fact, our service delivery model is most appropriate for small to medium size development companies who rely on their partners for quality, responsiveness and flexibility. For those companies where every dime matters and there is no excess to pay for redundant services.
Where maintaining control of your study and the relationship with your investigative sites is critical. So our relationships are highly collaborative, transparent, and supportive — a true partnership.About Us. Silicon Catalyst is the world's only incubator focused exclusively on semiconductor solution startups.
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