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The clinical research stage is resource-intensive, demanding in nature, and possess high risk. So, a fine balance is required for its successful execution. Many pharmaceutical and biotechnology industries are seeking support from CROs (Contract Research Organizations) to fulfill their research-intensive tasks. But unfortunately, this strategy turns out to be more challenging than being an opportunity. Here’s how:
CRO’s lack in providing in-depth information that is required by their clients for future risk management. This information includes, clinical trials that must be reported with key performance indicators (KPIs) (e.g., test times, error rates, and deviations) as standardized metrics to ensure quality and performance and only then, they are considered to be a viable one. And most of the time, CRO’s fail to fulfill this need.
CRO’s makes use of various systems to which they decline providing access to anyone not even their clients. This practice creates trust issues. On the other hand, when the document sharing & reviewing status is not updated regularly, this results in a lack of transparency and confidence towards the system.
Timelines to deliver drugs and medical devices is of utmost importance. CRO’s often fail to finish the timelines. With every slip in the timeline, costs are also increased, and the risk of several tasks on the critical path being unrealistic is also raised up to some extent.
A common complaint from sponsor companies is that CROs don’t provide dedicated resources to handle their projects. This results in missed deadlines and poor work quality.
Performing an assessment of SOPs and a skill gap analysis for CRO organizations is very important. If not done, the poor-quality operations and deliverables are what can be expected from CRO’s.
The need to navigate highly regulated promotional programs, meeting ever-increasing compliance, and fulfill the complex supply chains, requires proper document transactions. Depending upon CROs for such contracts that are key to the successful execution of these transactions, it seems difficult with the challenges they hold.
MSB Docs simplifies the processes while keeping up the security and compliance.Here’s how:
Choose a Digital Solution
Gain Full Control Over Document Transactions
MSB Docs helps in moving a new drug or device from its conception to FDA approval with a lesser need to maintain a staff for these services.
Gain control over the entire contract lifecycle and ensure each process is following the FDA regulations.
Forge collaborative and strategic partnership agreements with CROs
Enforce the use of flattened & fillable forms to meet FDA compliance.
Author all-inclusive Intellectual Property agreements to safeguard patented formulas
Track contractual milestones and identify supplier consolidation opportunities
Create, e-sign, store, and manage all contracts within a centralized repository.
Maintain an audit trail for all the changes made to a contract
Generate reports to increase transparency