Efficiency Isn't Accidental — It's by Designed

How to Run Clinical Trials Efficiently — Solving Five Major Pain Points to Help New Drug Companies Hit Every Milestone

Bringing a new drug from the laboratory to patients typically takes 10 to 15 years and billions of dollars in investment. Yet along this long road, it is often not the science itself that holds back progress, but the structural problems that recur throughout the execution of clinical trials.

According to multiple studies, roughly 80–86% of clinical trials worldwide fail to complete subject enrollment within their planned timeline, and about 30% of trials encounter delays after enrollment is complete due to data quality or regulatory issues. Every day of delay can represent up to millions of dollars in potential losses for a drug developer (Brøgger-Mikkelsen et al., 2020, JMIR).

For a CRO, EffPha's core value does not lie merely in “helping execute the trial,” but in proactively identifying and resolving these pain points so that every clinical milestone can be hit with precision.

We will systematically break down the five most common pain points in clinical trials and propose corresponding solution frameworks for biopharmaceutical companies looking to launch or optimize their clinical programs.

Pain Point 1: Inconsistent Regulatory Submission Quality (IND Submission Quality)

For Taiwanese biotech companies aiming to enter international markets, regulatory submissions are one of the most easily underestimated sources of risk. Taiwan's TFDA requires Chinese-language submission documents, the U.S. FDA has its own specific CTD format requirements, and the EU's EMA has separate requirements for the IMPD (Investigational Medicinal Product Dossier). When pursuing multiple national submissions simultaneously, the complexity of document version control grows exponentially.

A single regulatory document rejection can cost 2 to 3 months of re-preparation time at best, and at worst can affect the overall trial timeline or even the pace of subsequent licensing negotiations.

Ensuring regulatory quality requires working on both the “people” and “systems” dimensions simultaneously.

On the people side, a Regulatory Affairs team with multinational regulatory experience is indispensable. Taiwan's TFDA submissions have their own specific local requirements, and relying solely on the general ICH framework often leads to oversights in the details.

On the trial design side, the concept of “Regulatory Strategy Upfront” is especially important. During protocol design, EffPha's regulatory and biostatistics teams participate in reviewing the study design to confirm that the Primary and Secondary Endpoints meet the approval standards of the target market — effectively avoiding the tragedy of “discovering after the trial is complete that the data will not be accepted.”

EffPha Performance: First-cycle Approval Rate of over 95%

Pain Point 2: Excessive Trial Start-up Delay

From IND (Investigational New Drug) approval to First Patient First Visit (FPFV), a clinical trial in Taiwan takes 6 to 9 months on average. This gap is not an inevitable consequence of regulation itself, but stems from several factors that can be actively managed:

IRB (Institutional Review Board) review slots are limited — poor document quality can cause a single rejection to result in a 6-to-8-week delay. Legal review of the Clinical Trial Agreement (CTA) often involves multiple parties and is time-consuming. In multi-center trials, site start-up progress is often out of sync, preventing the overall trial from reaching enrollment speed in a timely manner.

The key to effectively compressing trial start-up time lies in “acting ahead of time” rather than “waiting to act.”

When a CRO has an established communication history with hospitals and legal departments, the time needed to negotiate contracts with sites can be shortened. At the same time, for multi-center trials, adopting a “Parallel Start-up” strategy — having all sites simultaneously conduct staff training, equipment verification, and document preparation rather than proceeding sequentially — is one strategy that can shorten the overall site activation timeline.

Based on each site's specific requirements, EffPha helps clients identify the most efficient start-up approach through Feasibility assessment, Site Selection, and Start-up Strategy planning.

Pain Point 3: Low Patient Recruitment Efficiency

This is the most far-reaching and most underestimated of all clinical trial pain points. Globally, 85% of clinical trials fail to complete enrollment on schedule (BioPharma Dive, 2019; Brøgger-Mikkelsen et al., 2020, JMIR), and about 30% of trial sites ultimately enroll zero subjects.

The reasons behind recruitment difficulty are multi-layered: patients are unaware a trial exists for them to join, informed consent forms are overly complex and raise refusal rates, physician referral willingness is inconsistent, and Inclusion/Exclusion Criteria are designed too strictly, excluding a large number of potential subjects. In Taiwan, the potential population for orphan (rare) diseases and certain tumor indications is inherently limited, making recruitment pressure even more pronounced.

Before a trial begins, a thorough Feasibility Study and Pre-study Visit play an extremely important role.

When the Feasibility assessment and Pre-Study Visit are done thoroughly and paired with an effective database system, the following can typically be identified early:

• Is the patient pool sufficient?
• Are the Inclusion/Exclusion Criteria too strict?
• Are multiple studies at the same site competing for the same patient population?
• What is the investigator's actual recruitment capacity?

In addition, trial design and selecting the appropriate biomarker are also key to clinical trial success. Adaptive Design plays an important role here. Through a Biomarker Enrichment strategy, the trial targets the population most likely to respond to treatment from the outset, reducing the time wasted on recruiting subjects who are “not suitable.”

Modern patient recruitment no longer relies on referrals from a single physician. An effective recruitment strategy can be achieved by integrating multiple layers:

Data-driven patient identification is the first layer. By connecting hospital Electronic Medical Record (EMR) systems, disease registries, and the government-promoted clinical trial match platform “Taiwan Clinical Research Intent Registration Platform”,  AI-assisted screening tools can automatically match patient characteristics against enrollment criteria, increasing the speed of identifying potential subjects several-fold while substantially reducing the manual review workload.

Collaboration with patient advocacy groups and disease advocacy organizations is the second layer. For rare disease trials, partnerships with patient groups not only reach patients outside the mainstream healthcare system but also increase patient trust in and willingness to participate in the trial.

Through Protocol Design, Feasibility Study and Pre-Study Visit work, EffPha helps sponsors build a sound project plan before the trial begins and reach the consensus

with client so that the goals of all stakeholders stay aligned.

Pain Point 4: Data Integrity & GCP Compliance Risk

In GCP (Good Clinical Practice) audits, data consistency issues are the most common finding. In multi-center trials, Clinical Research Coordinators (CRCs) at different sites often have inconsistent habits when using the Electronic Data Capture (EDC) system, which can cause Protocol Deviations to accumulate over time. If not detected and corrected promptly, this can at minimum increase the data-cleaning workload, and at worst affect regulators' assessment of trial integrity.

This is especially critical when preparing for audits ahead of an FDA Pre-NDA or BLA review: if past data issues were not systematically documented and addressed, they can become a stumbling block to approval.

EffPha pairs each trial with a real-time data quality monitoring system, so that anomalous data appearing in the EDC is automatically flagged and triggers a query within 24 hours, preventing issues from accumulating until late in the trial.

EffPha Performance: Comprehensive data quality control throughout the trial, effectively shortening the time needed to confirm data quality during the statistical analysis stage after Database Lock.

Pain Point 5: Cross-border Coordination and Communication Costs

Cross-border coordination in multinational, multi-center trials may appear on the surface to be a matter of time zones and language, but at its core it is a problem of information asymmetry and decision-making speed. Trial sites in Asia, Oceania, the Americas, and Europe often report to different project managers, leaving the sponsor unable to grasp overall progress in real time; a decision requiring sign-off from multiple parties can take weeks of back-and-forth email exchanges.

This communication friction is most apparent at the trial's key junctures — such as Protocol Amendments, SAE reporting, and implementation of IDMC recommendations — and a delay at any one of these junctures can trigger a chain reaction that affects the overall trial timeline.

Effective cross-border coordination requires a clear command structure. The “Lead CRO Model” is increasingly common in multinational, multi-center trials: a single CRO serves as the overall coordinating party, providing a single point of contact for the sponsor, while local Sub-CROs or on-site support teams are established in each country — forming a clear two-tier structure that eliminates the confusion of having too many parties communicating independently.

At the tooling level, a unified, real-time e-TMF (electronic Trial Master File) system lets the sponsor track key metrics at any time — enrollment numbers, data quality indicators, and Protocol Deviation rates across all sites — providing an additional information tool beyond the passive management of scheduled status meetings.

An Integrated View: A Clinical Trial Milestone Management Framework

Bringing together the solutions to the five pain points above, efficient clinical trial execution requires a milestone-driven management framework, rather than relying solely on individual tactical improvements.

Key milestones should span the entire trial: IND approval, Site Initiation Visit (SIV) completion, First Patient First Visit (FPFV), 50% enrollment completion, Last Patient Last Visit (LPLV), Database Lock, and completion of the final Clinical Study Report (CSR). Each milestone should have a clear target date, an accountable owner, and a quantifiable measure of completion.

More importantly, this framework requires forward-looking risk management rather than reactive problem-solving. Through an early-stage risk assessment matrix, potential delay risks for each milestone — and their corresponding mitigation measures — are identified, keeping the entire execution team clearly aware of “where things could go wrong” and allowing response plans to be deployed in advance.

Efficiency Isn't Accidental — It's by Designed

Efficient clinical trial execution has never been the result of getting just one part right. It is the outcome of tightly integrating three things: forward-looking trial design (regulatory strategy, adaptive design), systematic execution management (standardized processes, real-time monitoring), and cross-functional professional coordination (regulatory affairs, biostatistics, data management, and clinical operations).

For companies planning clinical trials for new drugs, medical devices, or cell therapies, the core question in choosing a CRO partner should not simply be “how many trials have you run,” but rather “how do you systematically identify and resolve these pain points so that my trial does not become part of that 80% delay statistic.”

This is exactly what EffPha does every day.

References

Brøgger-Mikkelsen M, et al. (2020). Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. JMIR, PMID: 33146627.

Round, R. (2019). Decentralized Clinical Trials: Are We Ready to Make the Leap? BioPharma Dive (PAREXEL sponsored content). January 29, 2019.

Wong CH, et al. (2019). Estimation of clinical trial success rates and related parameters. Biostatistics, 20(2): 273–286.

FDA. (2019). Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry.

For individual consultation regarding your trial plan, please feel free to reach out through the contact form on our official website or contact your project lead directly.