While finding the right publishing vendor provides tremendous value to an organization short on internal resources, it is important to be thinking beyond eCTD publishing. Pairing with a vendor that can offer extensive regulatory and communications strategy, science and solutions experience brings numerous synergies. The understanding that a vendor can be well versed in a program and quickly provide services as needed across a multitude of potential needs can provide higher quality submissions at expedited speeds, while accommodating to the numerous curveballs that will inevitably be thrown your way.
Thinking Beyond eCTD Publishing
Having a well-constructed regulatory submission strategy that is interwoven into a sponsor’s operational program is even more critical to achieving success than in the past. Between the escalating competition, speed, cost, and risk; benefit pressures on sponsors; the need for payers to see ‘best-in-value’ data of a drug to justify adding it to the formulary; new global regulatory expectations for electronic submissions; or the complexity of the drug itself—strategy is key.
Regulatory and Medical Writing
There is tremendous complexity and variability in any drug development program. It takes leadership and strategy to develop one story and a plan that considers all variables and contingencies. Sponsors need a trusted, agile, and experienced partner not only to prepare these documents, but also to provide complete program guidance and management to address the industry’s greatest regulatory challenges and growing demands.
Mitigating Risk and Ensuring Compliance
As the issue of transparency and disclosure (T&D) of clinical trial information has grown in importance, so has the recognition that sharing clinical trial information is a key step toward increasing trust between the public and the industry. More importantly, increased transparency regarding data about ongoing research could spur new products or therapeutic approaches, widen the participation of needed subjects, and potentially avoid unnecessary trials.
Life Sciences Technology
Artificial Intelligence (AI) technology is revolutionizing life sciences, and over the next decade, will continue to enable advancements at unprecedented rates. Working with a vendor who is developing and utilizing AI technology solutions translates to significant time and cost-savings.
Solutions Beyond eCTD Publishing
Synchrogenix is committed to a continuum of innovation. Through technology-enabled solutions, we optimize our contributions from early phase development through lifecycle management. We effectively bridge content generation to knowledge communication with our Artificial Intelligence and Regulatory platforms to reach various stakeholders.
Synchrogenix provides regulatory strategy, science, and solutions to pharmaceutical, device, diagnostics, and tobacco companies worldwide. With eighteen locations across three continents, Synchrogenix meets the needs of sponsors around the clock and around the globe.