Evolving regulatory demands require well thought out, conscientious clinical trial designs, implemented by a dedicated and experienced clinical research team. The high-level vigilance necessary for your program requires detailed planning, oversight and execution; ensuring costs are managed and personnel motivated. Thorough planning, by forward-thinking statisticians, regulatory specialists and medical experts is invaluable to keeping your program running at the highest regulatory, ethical and clinical levels.

We believe that early collaboration saves money, hassles, headaches and time, so we support clients as early as possible, helping with GMP planning and compliance.  Our QA and CMC early trial production involvement addresses future manufacturing, scale-up processes and clinical integration. We continue support through regulatory consulting and action-oriented experts, encouraging proactive communication with regulatory authorities and compliance through solid clinical trial planning and protocol development. Often companies, especially start-up organizations, will delay involving a CRO early in the clinical development stage in order to save money by doing much of the upfront work themselves. This approach frequently leads to lost time and extra costs later that could have been avoided with early guidance by an experienced team.

Eighty percent (80%) of our contracts over the past 16 years involve imaging. This experience has led to innovative trial designs, collaborative FDA relationships and comprehensive program management, maximizing your study’s imaging data impact.

The importance of properly powering your study is often not appreciated. Our experienced statisticians understand what is required and can often reduce costs and regulatory complications and frustrations, including additional trials. Our statisticians are sought after experts, established in the field, and have been requested to participate in internal FDA workshops. 

Successful marketing campaigns for drugs or medical devices include ensuring the campaign is compliant with FDA regulations. The last thing any company needs are additional costs, time lost or bad publicity from an FDA warning letter or an investigation by the Department of Justice due to questionable promotional claims. To help companies create compliant promotional campaigns, Certus has assembled a full promotional review team – legal, regulatory, and medical. With over 25 years combined experience, the promotional team will review promotional materials and design a compliant launch while still allowing effective, creative campaigns.

Certus also offers training courses in regulatory advertising/promotion, and assistance creating a Target Product Profile (TPP). Certus can help design pre-clinical and clinical studies to create the scientific and medical data needed to support the marketing group in developing a successful launch for a new drug or medical device.

We have been told that sponsors do not want to feel like they have contracted with a company to run their trial; they want to feel like they have an additional, dedicated team that is committed to the success of your trial. This team must integrate with your team and be responsive, knowledgeable, available and approachable.

Strong communication is essential to any successful clinical project and establishing a good relationship promotes the framework for successful communication. Industry research from 2011 indicates the primary reason you, the sponsor, will chose one service provider over another is how well the sponsor and service provider teams work together. Our experience has taught us to lay the groundwork early so both teams understand the importance communication holds. We qualify our clients, while they qualify us, so that we are sure we will work well together. When goals are shared and the personalities that work together mesh well, sensitive situations and potential problems can be addressed proactively and effectively.

After the trial has been designed properly, and the sites have been chosen and are operating; frequent communication is paramount and must be maintained. Too often CROs will sit back at this point and not manage the study actively. Valuable time can be lost because there is not a focus on enrollment. Timelines that have been carefully developed must be adhered to. We take your timelines very seriously. Additionally, making sure that FDA regulatory requirements and good clinical practices (GCPs) are being adhered to along the way is mandatory. We ensure that the sites are documenting properly and adhering to all the study requirements.

“Data is King” and if your clinical trial results are not clear, time and money has been wasted; a lot of it!! Clean data starts with experienced statisticians with a well designed CRF (Case Report Form) and database.

Regulatory submissions can determine a clinical trial’s success or failure; starting with filing the IND all the way to the NDA submission. Understanding what FDA needs to see and how to present the data can make the difference in approval, delay, or failure. Don’t ever underestimate the importance of a good relationship with FDA.